Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
- NDC Code(s): 55319-053-14, 55319-053-21
- Packager: Family Dollar Stores, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
-
Warnings
Liver warning:This product contains acetaminophen. 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:acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- 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 reach of children.
-
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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Label)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Carton)
FAMILY
Wellness ™
COMPARE TO THE ACTIVE
INGREDIENT IN EXTRA STRENGTH
TYLENOL RAPID RELEASE GELS*
EXTRA STRENGTH
PAIN RELIEF RAPID
RELEASE
Acetaminophen Gelcaps, 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels
FOR ADULTS ACTUAL SIZE
100 GELCAPS DO NOT USE WITH OTHER MEDICINES
500 mg Each CONTAINING ACETAMINOPHEN NDC 55319-053-21
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-053 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 AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (and Blue with Grey Band) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code J;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-053-14 1 in 1 CARTON 08/11/2023 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55319-053-21 1 in 1 CARTON 08/11/2023 2 100 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 Drug M013 08/11/2023 Labeler - Family Dollar Stores, LLC (024472631) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 analysis(55319-053) , manufacture(55319-053)
