Label: ACTIDOGESIC DF- acetaminophen, dexbrompheniramine maleate tablet
- NDC Code(s): 63102-403-10
- Packager: Actipharma, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each caplet)
- Purpose
- INDICATIONS & USAGE
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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.
Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
Ask a doctor before use
• if you have liver disease • if you are taking the blood thinning drug warfarin.
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. 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
- Other Information
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
• ANALGESIC • FEVER REDUCER
• ANTIHISTAMINE
Contains the same active ingredients as Dologesic® - DF*
SUGAR FREE
DYE FREE
ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
Manufactured in the USA
for ActiPharma, Inc.
Dorado, PR 00646.
Tel: (787) 608-0882
* Dologesic® - DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
- Packaging
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INGREDIENTS AND APPEARANCE
ACTIDOGESIC DF
acetaminophen, dexbrompheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-403 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 1 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score 2 pieces Shape capsule Size 17mm Flavor Imprint Code A403 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-403-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/10/2020 Labeler - Actipharma, Inc (079340948)