Actidogesic
Dexbrompheniramine maleate, acetaminophen · Tablet · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg
Purpose
Purpose Pain reliever/Fever reducer Antihistamine
Uses
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
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.
Keep out of reach of children
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
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.
Other information
Other information
• Tamper Evident. Do not use if inner seal is torn, broken, or missing
• Store at controlled room temperature 15°-30°C (59°-86°F)
• Avoid excessive heat or humidity
Inactive ingredients
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?
Questions or Comments? Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882
Label text from the FDA structured product label by ACTIPHARMA, LLC (revised Aug 18, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dexbrompheniramine Maleate in 1 product
- Acetaminophen in 1 product
Actidogesic NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63102-402 | Dexbrompheniramine Maleate 1 mg/1; Acetaminophen 500 mg/1 Tablet | ACTIPHARMA, LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Actidogesic used for?
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.
Who makes Actidogesic?
Actidogesic is listed by 1 labeler in the FDA NDC directory, including ACTIPHARMA, LLC.