Label: ACETAMINOPHEN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 55315-987-24 - Packager: FFREDS, INC
- 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 July 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product - Allergy alert
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children.
- Overdose warning
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Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor - Other information
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Inactive ingredients
ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, titanium dioxide, yellow iron oxide.
- Questions or comments?
- EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 24 GELCAPS 500 mg each
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-987 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMMONIA (UNII: 5138Q19F1X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color gray (one red opaqe and one blue-gray hard gelatin shells) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-987-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/17/2017 Labeler - FFREDS, INC (005866116)