Label: ACETAMINOPHEN 500 MG- acetaminophen tablet
- NDC Code(s): 84324-021-01
- Packager: NUVICARE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
- Warnings
- OTHER SAFETY INFORMATION
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY 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 Caplets every 6 hours while symptoms last
- do not take more than 6 caplets 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 500 MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84324-021 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, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape capsule Size 17mm Flavor Imprint Code S500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84324-021-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/01/2025 Labeler - NUVICARE LLC (119257565)