Quick answers
- What is Chlorpheniramine, dextromethorphan and phenylephrine used for?
- The Drug Facts label of Bio-Rytuss (Advanced Generic Corporation) lists these uses: temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat temporarily restores freer beathing through the nose..
- Do I need a prescription for Chlorpheniramine, dextromethorphan and phenylephrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Chlorpheniramine, dextromethorphan and phenylephrine been recalled?
- FDA enforcement reports list 2 recalls of products on this page; the newest started March 15, 2021. A recall usually concerns specific products or lots, not every brand.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Bio-Rytuss · Advanced Generic Corporation
Chlorpheniramine maleate 2 mg/5 mL · Dextromethorphan hydrobromide 10 mg/5 mL · Phenylephrine hydrochloride 5 mg/5 mL, liquid (oral)
Active ingredient (in each 5 mL tsp.)
Purpose Chlorpheniramine Maleate 2 mg Antihistamine Dextromethorphan Hydrobromide 10 mg Cough Suppressant Phenylephrine Hydrochloride 5 mg Nasal Decongestant
Purpose
Antihistamine Cough Suppressant Nasal Decongestant
Uses
temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat temporarily restores freer beathing through the nose.
Warnings
Ask doctor before use if you have Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema. Heart disease High blood pressure Thyroid Disease Diabetes Difficulty in urinating due to enlarged prostate gland Glaucoma Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.
When using this product
Do not use
more than directed May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.
Do not use
To sedate a child or to make a child sleepy If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription that contains an MAOI, ask your doctor or pharmacist before taking this product
Stop use and ask a doctor if
you you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.
If pregnant or breast-feeding
ask a doctor before use
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center immediately
Directions
do not take more than 6 doses in any 24 hour period
| adults and children 12 years of age | 2 teaspoonful (10 mL) every 4-6 hours |
| children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4-6 hours |
| children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) every 4-6 hours |
Inactive ingredients
Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.
Questions?
1-305-403-3788
— FDA label of Bio-Rytuss, Advanced Generic Corporation, effective December 30, 2025. See the official label on DailyMed →
Gencontuss · Kramer Novis
Chlorpheniramine maleate 2 mg/5 mL · Dextromethorphan hydrobromide 10 mg/5 mL · Phenylephrine hydrochloride 5 mg/5 mL, solution (oral)
Active ingredient (in each 5mL tsp)
Chlorpheniramine Maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg
Purpose
Antihistamine Cough suppressant Nasal decongestant
Uses
- For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever.
- Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold.
- Temporarily restores freer breathing through the nose.
Warnings
Do not use
- to sedate a child or to make a child sleepy.
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional condition) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if
you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- excitability occurs, especially in children
- symptoms do not improve within 7 days or are accompanied by fever
- cough persists for more than 1 week tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Directions
Do not exceed 6 doses in 24 hours.
| Adults and children 12 years of age and older | 2 teaspoonfuls (10 mL) every 4 hours. |
| Children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4 hours. |
| Children 2 to under 6 years of age | Ask a doctor. |
Inactive ingredients
citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.
Questions?
call weekdays from 8 AM to 4 PM AST at 1.787.767.2072
— FDA label of Gencontuss, Kramer Novis, effective December 4, 2025. See the official label on DailyMed →
Ed A-Hist Dm · Edwards Pharmaceuticals, Inc.
Chlorpheniramine maleate 4 mg/5 mL · Dextromethorphan hydrobromide 15 mg/5 mL · Phenylephrine hydrochloride 10 mg/5 mL, liquid (oral)
Active ingredient (in each 5 mL teaspoonful)
Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant
Purpose
Active Ingredients (in each 5 mL teaspoonful) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do not use
this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Do not use
this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When using this product
excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur
If pregnant or breastfeeding
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage
| Adults and children 12 years of age and over: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children under 6 years of age: | Consult a doctor. |
Inactive ingredients
Artificial and Natural Banana Flavor, Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.
Questions?
Question? Comments? Call 1-800-543-9560
— FDA label of Ed A-Hist Dm, Edwards Pharmaceuticals, Inc., effective December 31, 2025. See the official label on DailyMed →
Phenagil · Gil Pharmaceutical Corp.
Chlorpheniramine maleate 3.5 mg · Dextromethorphan hydrobromide 29 mg · Phenylephrine hydrochloride 10 mg, tablet (oral)
Active ingredient
Drug Facts Active ingredients (in each tablet) Chlorpheniramine maleate 3.5 mg Dextromethorphan HBr 29 mg Phenylephrine HCI 10 mg
Purpose
Antihistamine Cough suppressant Nasal decongestant
Uses
Temporarily relieves:
- cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
- nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose.
- sneezing.
- itchy, watery eyes.
- itching of the nose or throat.
- temporarily restores freer breathing through the nose.
Warnings
Do not use
- to sedate a child or to make a child sleepy.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if
you have
- heart disease.
- high blood pressure.
- thyroid disease.
- diabetes.
- trouble urinating due to an enlarged prostate gland.
- glaucoma.
- cough that occurs with too much phlegm (mucus).
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask a doctor or pharmacist before use if
you are
- taking sedatives or tranquilizers.
- taking any other oral nasal decongestant or stimulant.
When using this product
- do not use more than directed.
- may cause drowsiness.
- avoid alcoholic beverages.
- alcohol, sedatives, and tranquilizers may increase drowsiness.
- be careful when driving a motor vehicle or operating machinery.
- excitability may occur, especially in children.
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless.
- symptoms do not get better within 7 days or are accompanied by fever.
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Adults and Children 12 years and over. : Take one tablet every 6-8 hours. Do not take more than 4 tablets in a 24 hour period.
- Children 6 to 12 years of age : Take 1/2 tablet every 6-8 hours. Do not take more than 2 tablets in a 24 hour period.
- Children under 6 years : Consult a doctor.
Other information
- store at room temperature.
- do not use if safety seal is broken or missing.
Inactive ingredients
Hydroxypropyl Methylcellulose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate and Polyethylene Glycol.
Questions?
Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects. MANUFACTURED FOR: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 Label revised: 04/22
— FDA label of Phenagil, Gil Pharmaceutical Corp., effective September 2, 2026. See the official label on DailyMed →
Giltuss Allergy Plus Cough and Congestion · Gil Pharmaceutical Corp
Chlorpheniramine maleate 4 mg/10 mL · Dextromethorphan hydrobromide 20 mg/10 mL · Phenylephrine hydrochloride 10 mg/10 mL, solution (oral)
Active ingredient (in each 10 mL)
Chlorpheniramine maleate, USP 4 mg Dextromethorphan HBr, USP 20 mg Phenylephrine HCl, USP 10 mg
Purpose
Antihistamine Cough suppressant Nasal decongestant
Uses
temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose
Warnings
Do not use
to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if
you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers taking any other oral nasal decongestant or stimulant
When using this product
do not use more than directed may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness effect be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Stop use and ask a doctor if
you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by a fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
If pregnant or breastfeeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, seek professional help or contact a Poison Control Center right away.
Directions
Do not take more than 6 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product mL=milliter
| adults and children 12 years and over | 10 mL every 4 to 6 hours |
| children 6 to under 12 years | 5 mL every 4 to 6 hours |
| children under 6 years | Consult a Doctor |
Inactive ingredients
citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose
Questions?
Call 1-787-848-9114 , Monday-Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.
— FDA label of Giltuss Allergy Plus Cough and Congestion, Gil Pharmaceutical Corp, effective October 9, 2025. See the official label on DailyMed →
NeoTuss Plus · DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Chlorpheniramine maleate 4 mg/5 mL · Dextromethorphan hydrobromide 30 mg/5 mL · Phenylephrine hydrochloride 7.5 mg/5 mL, liquid (oral)
Active ingredient
Dextromethorphan HBr 30 mg / 5 mL Chlorpheniramine Maleate 4 mg / 5 mL Phenylephrine HCl 7.5 mg / 5 mL
Purpose
Antitussive, Antihistamine, and Decongestant. Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus. Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies. Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
Uses
Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period. Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor. Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus. Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies. Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
Warnings
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.
Do not use
this product if the seal is torn, broken or missing. Do not take this product if you have a persistent or chronic cough, such as occurs with smoking, asthma, emphysema or when cough is accompanied by excessive secretions except under the advice and supervision of a physician. Do not take other sedatives, tranquilizers or alcohol while taking this medication.
Do not use
if you are taking monoamine oxidase inhibitors or other sympathomimetics. If you are pregnant or breast-feeding, ask a health professional before using this product. Shake well before use. Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus. Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies. Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies. In case of accidental overdose seek the advice of a health professional or contact a Poison Control Center immediately.
Directions
Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period. Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor.
Other information
Pharmacist: Preserve and dispense in tight-light resistance containers as defined in the USP. Store between 15°-30°C (59°-86°F). Do not accept this product if the safety seal is broken or missing. Keep a box for information.
Inactive ingredients
Artificial and natural flavors, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sorbitol, and sucralose.
— FDA label of NeoTuss Plus, DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals, effective December 18, 2025. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Chlorpheniramine maleate 2 mg/5 mL · Dextromethorphan hydrobromide 10 mg/5 mL · Phenylephrine hydrochloride 5 mg/5 mL · liquid (oral) · 5 products
Chlorpheniramine maleate 2 mg/5 mL · Dextromethorphan hydrobromide 10 mg/5 mL · Phenylephrine hydrochloride 5 mg/5 mL · solution (oral) · 3 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Gencontuss | Kramer Novis | DailyMed |
| Giltuss Childrens Allergy Plus | Dextrum Laboratories Inc. | DailyMed |
| Giltuss Childrens Allergy Plus Cough and Congestion | Gil Pharmaceutical Corp | DailyMed |
Chlorpheniramine maleate 4 mg/5 mL · Dextromethorphan hydrobromide 15 mg/5 mL · Phenylephrine hydrochloride 10 mg/5 mL · liquid (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Ed A-Hist Dm | Edwards Pharmaceuticals, Inc. | DailyMed |
| NoHist DM | Larken Laboratories, Inc. | DailyMed |
Chlorpheniramine maleate 3.5 mg · Dextromethorphan hydrobromide 29 mg · Phenylephrine hydrochloride 10 mg · tablet (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Phenagil | Gil Pharmaceutical Corp | DailyMed |
Chlorpheniramine maleate 4 mg/10 mL · Dextromethorphan hydrobromide 20 mg/10 mL · Phenylephrine hydrochloride 10 mg/10 mL · solution (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Giltuss Allergy Plus | Dextrum Laboratories Inc. | DailyMed |
| Giltuss Allergy Plus Cough and Congestion | Gil Pharmaceutical Corp | DailyMed |
Chlorpheniramine maleate 4 mg/5 mL · Dextromethorphan hydrobromide 30 mg/5 mL · Phenylephrine hydrochloride 7.5 mg/5 mL · liquid (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| NeoTuss Plus | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | DailyMed |
Chlorpheniramine maleate 4 mg/30 mL · Dextromethorphan hydrobromide 10 mg/30 mL · Phenylephrine hydrochloride 10 mg/30 mL · liquid (oral) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Father Johns Cough Medicine Plus | Oakhurst Company | DailyMed |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| chlorpheniramine maleate 4 mg/5 mL · dextromethorphan hydrobromide 15 mg/5 mL · phenylephrine hydrochloride 10 mg/5 mL liquid | Generic | $0.0668 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Gil Pharmaceutical Corp4 products
- Dextrum Laboratories Inc.4 products
- Edwards Pharmaceuticals, Inc.1 product
- DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals1 product
- Advanced Generic Corporation1 product
- Larken Laboratories, Inc.1 product
- Domel Laboratories1 product
- Okendpharma, Inc.1 product
- Oakhurst Company1 product
- Kramer Novis1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.
-
March 15, 2021 · Class II · Terminated · D-0507-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046 — Cardinal Health Inc.
-
June 21, 2019 · Class II · Terminated · D-1497-2019
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, ND — Pharma-Natural Inc.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.