Quick answers
- What is Acetaminophen and dexbrompheniramine used for?
- The Drug Facts label of Actidogesic (Actipharma, LLC) lists these uses: For the temporary relief of minor aches and pains associated with; headache; muscular aches; backaches; minor arthritis pain; common cold; toothaches; menstrual cramps; temporarily reduces fever; itchy, watery eyes due to hay fever..
- Do I need a prescription for Acetaminophen and dexbrompheniramine?
- 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 Acetaminophen and dexbrompheniramine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
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.
Actidogesic · Actipharma, LLC
Acetaminophen 500 mg · Dexbrompheniramine maleate 1 mg, tablet (oral)
Active ingredient (in each caplet)
Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg
Purpose
Pain reliever/Fever reducer Antihistamine
Uses
- For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- backaches
- minor arthritis pain
- common cold
- toothaches
- menstrual cramps
- temporarily reduces fever
- itchy, watery eyes due to hay fever.
Warnings
Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take
- more than 8 caplets (4,000 mg) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
Do not use
- with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen , ask a doctor or pharmacist
- if you are allergic to acetaminophen or any of the inactive ingredients in the product
- for more than 10 days for pain, unless directed by a doctor.
Ask a doctor before use if
you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if
you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers Stop using this product and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Do not exceed recommended dosage
| Adults and children 12 years of age and older | Take 2 caplets every 4 to 6 hours as needed, do not exceed 8 caplets in 24 hours, or as directed by a doctor, do not use for more than 10 days unless directed by a doctor. |
| Children under 12 years of age | Do not use. |
Inactive ingredients
FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerol mono and dicaprylocaprate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol graft polyethylene glycol copolymer, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions?
Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882
— FDA label of Actidogesic, Actipharma, LLC, effective August 18, 2025. See the official label on DailyMed →
Dologen · Kramer Novis
Acetaminophen 500 mg · Dexbrompheniramine maleate 2 mg, tablet (oral)
Active ingredient (in each tablet)
Acetaminophen 500 mg Dexbrompheniramine maleate 2mg
Purpose
Pain reliver/fever reducer Antihistamine
Uses
- for the temporary relief of minor aches and pains associated with
- headache
- the common cold
- toothache
- muscular aches
- backache
- premenstrual and menstrual cramps
- the minor pain from arthritis and reduces fever.
- for the temporary relief of
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever.
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product.
- Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blister
- rash. if a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- if you are allergic to acetaminophen or any of the inactive ingredients in the product
- this product unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
- if you are taking sedatives or tranquilizers, without first consulting your doctor.
Ask a doctor before use if
you have liver disease
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
When using this product
- may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling in present
- any new symptoms appear 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years of age and older | take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. |
| children under 12 years of age | consult a doctor |
Inactive ingredients
magnesium stearate, microcrystalline cellulose, sodium starch glycolate, steric acid
Questions?
1-787-767-2072 Call weekdays from 8:00 am to 4:00 pm AST. You may also report serious side effects to this phone number
— FDA label of Dologen, Kramer Novis, effective December 5, 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.
Acetaminophen 500 mg · Dexbrompheniramine maleate 1 mg · tablet (oral) · 4 products
Acetaminophen 500 mg · Dexbrompheniramine maleate 2 mg · tablet (oral) · 2 products
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.
- Llorens Pharmaceutical International Division2 products
- Kramer Novis2 products
- Actipharma, LLC2 products
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
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.