Label: EXCINOL ARTHRITIS (ACETAMINOPHEN)- acetaminophen tablet, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 49638-103-30 - Packager: America Medic & Science, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 22, 2019
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- Official Label (Printer Friendly)
- Excinol Arthritis (Acetaminophen) 650 mg
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Overdose warning
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
do not take more than directed (see overdose warning).
- take 2 caplets every 8 hours with water.
- Swallow whole—do not crush, chew, split or dissolve.
- Do not take more than 6 caplets in 24 hours.
- Do not use for more than 10 days unless directed by a doctor.
Children
- Under 18 years of age ask a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- Excinol Arthritis (Acetaminophen) 650 mg
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INGREDIENTS AND APPEARANCE
EXCINOL ARTHRITIS (ACETAMINOPHEN)
acetaminophen tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape capsule Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49638-103-30 1 in 1 CARTON 01/17/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/17/2019 Labeler - America Medic & Science, LLC (071065464) Registrant - America Medic & Science, LLC (071065464) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc 037052099 manufacture(49638-103)