Label: ACTIDOGESIC- dexbrompheniramine maleate, acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63102-402-10 - Packager: ACTIPHARMA, INC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 4, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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ASK DOCTOR
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.
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DO NOT USE
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription) 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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DOSAGE & ADMINISTRATION
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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACTIDOGESIC
dexbrompheniramine maleate, acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-402 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 1 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score 2 pieces Shape capsule Size 17mm Flavor Imprint Code A402 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-402-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/14/2016 Labeler - ACTIPHARMA, INC (079340948) Registrant - ACTIPHARMA, INC (079340948)