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Over-the-counter medicine · no prescription needed

Codeine and guaifenesin

Cough, cold and flu

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

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.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Codeine and guaifenesin used for?
The Drug Facts label of Guaifenesin and Codeine Phosphate (Cardinal Health 107, LLC) lists these uses: temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants; helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Do I need a prescription for Codeine and guaifenesin?
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 Codeine and guaifenesin been recalled?
FDA enforcement reports list 2 recalls of products on this page; the newest started January 7, 2025. 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.

Guaifenesin and Codeine Phosphate · Cardinal Health 107, LLC

Codeine phosphate 10 mg/5 mL · Guaifenesin 100 mg/5 mL, solution (oral)

Active ingredient

in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

Purpose

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Warnings

Do not use

  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

Ask a doctor before use if

you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if

you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if

  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.

Directions

take every 4 hours

  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over 10 mL (2 teaspoonfuls)
children 6 to under 12 years of age 5 mL (1 teaspoonful)
children under 6 years of age Consult a doctor

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions?

Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.

— FDA label of Guaifenesin and Codeine Phosphate, Cardinal Health 107, LLC, effective June 2, 2026. See the official label on DailyMed →

Guaifenesin and Codeine Phosphate · PAI Holdings, LLC

Codeine phosphate 20 mg/10 mL · Guaifenesin 200 mg/10 mL, solution (oral)

Active ingredient

in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

Purpose

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Warnings

Do not use

in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

Ask a doctor before use if

you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if

you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age.

Directions

take every 4 hours do not exceed 6 doses in 24 hours a special measuring device should be used to give an accurate dose of this product to children under 6 years of age giving a higher dose than recommended by a doctor can result in serious side effects for a child

adults and children 12 years and over10 mL (2 teaspoonfuls)
children 6 to under 12 years of age5 mL (1 teaspoonful)
children under 6 years of ageConsult a doctor

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions?

Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.

— FDA label of Guaifenesin and Codeine Phosphate, PAI Holdings, LLC, effective September 6, 2024. See the official label on DailyMed →

MAR-COF CG Expectorant · Marnel Pharmaceuticals, LLC

Codeine phosphate 7.5 mg/5 mL · Guaifenesin 225 mg/5 mL, syrup (oral)

Active ingredient (in each teaspoonful (5 mL)

) Purpose Codeine Phosphate 7.5 mg Antitussive Guaifenesin 225 mg Expectorant

Purpose

Active ingredients (in each teaspoonful (5 mL)) Purpose Codeine Phosphate 7.5 mg Antitussive Guaifenesin 225 mg Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.

Warnings

Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs

When using this product

giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age may cause or aggravate constipation

Stop use and ask a doctor if

symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

If pregnant or breast-feeding

ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not exceed 6 doses in 24 hours.

Adults and children 12 years of age and over1 ½ tsp (7.5 mL) every 4-6 hours
Children 6 to under 12 years of age¾ tsp (3.75 mL) every 4-6 hours
Children under 6 years of ageConsult a doctor

Inactive ingredients

Citric Acid, Flavors, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol

— FDA label of MAR-COF CG Expectorant, Marnel Pharmaceuticals, LLC, effective March 15, 2024. 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.

Codeine phosphate 10 mg/5 mL · Guaifenesin 100 mg/5 mL · solution (oral) · 11 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Codeine-Guaifenesin A-S Medication Solutions DailyMed
Codeine-Guaifenesin Bryant Ranch Prepack DailyMed
Codeine-Guaifenesin Method Pharmaceuticals, LLC DailyMed
Codeine-Guaifenesin NuCare Pharmaceuticals, Inc. DailyMed
Codeine-Guaifenesin Proficient Rx LP DailyMed
Codeine-Guaifenesin Westminster Pharmaceuticals, LLC —
Guaifenesin and Codeine Phosphate A-S Medication Solutions DailyMed
Guaifenesin and Codeine Phosphate Cardinal Health 107, LLC DailyMed
Guaifenesin and Codeine Phosphate PAI Holdings, LLC DailyMed
Guaifenesin and Codeine Phosphate Preferred Pharmaceuticals Inc. —
Codeine phosphate 20 mg/10 mL · Guaifenesin 200 mg/10 mL · solution (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Guaifenesin and Codeine Phosphate PAI Holdings, LLC DailyMed
Codeine phosphate 7.5 mg/5 mL · Guaifenesin 225 mg/5 mL · syrup (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
MAR-COF CG Expectorant Marnel Pharmaceuticals, LLC 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.

NADAC per unit for Codeine and guaifenesin, by strength and form
Strength and formGeneric or brandPharmacies pay
codeine phosphate 10 mg/5 mL · guaifenesin 100 mg/5 mL
solution
Generic $0.0308–$0.0630 per mL
6 packages, lowest to highest

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.

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.

  1. January 7, 2025 · Class III · Terminated · D-0222-2025

    Superpotent; sodium benzoate preservative

    Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 — PAI Holdings, LLC. dba Pharmaceutical Associates Inc

  2. December 12, 2017 · Class II · Terminated · D-0210-2018

    Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

    Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16 — Woodfield Pharmaceutical, LLC

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. 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.

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