ACTIDOGESIC
ACTIDOGESIC
697da3f9-9888-4d41-ba83-87ca9bf1e54b
HUMAN OTC DRUG LABEL
Aug 18, 2025
ACTIPHARMA, LLC
DUNS: 079340948
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexbrompheniramine maleate, acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packaging
INDICATIONS & USAGE SECTION
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.
SPL UNCLASSIFIED SECTION
•ANALGESIC •FEVER REDUCER •ANTIHISTAMINE
Contains the same active ingredients as Dologesic®
SUGAR FREE
ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NET
Manufactured in the USA with imported ingredients for ActiPharma, LLC San Juan, PR 00917
*Dologesic® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen, 500 mg
Dexbrompheniramine Maleate, 1 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/Fever reducer
Antihistamine
WARNINGS SECTION
Warnings
Liver Warning: This product containsacetaminophen. 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 containingacetaminophen
(prescription or non-prescription) this will provide more than the recommended
dose (overdose) ofacetaminophen and could cause serious health concerns.
If you are not sure whether a drug containsacetaminophen, ask a doctor or
pharmacist • if you are allergic toacetaminophen 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.
DOSAGE & ADMINISTRATION SECTION
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. |
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or Comments?
Call weekdays from 8:00 AM - 4:00 PM, AST at1-787-608-0882