Label: ACETAMINOPHEN- pain reliever tablet
- NDC Code(s): 68599-4681-3
- Packager: McKesson
- 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 March 15, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:- more than 8 tablets 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
If a skin reaction occurs, stop use and seek medical help right away.
-
STOP USE
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if you have
- liver disease
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
Stop using and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
If pregnant or breast-feeding, ask a health professional before use.
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- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
pain reliever tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-4681 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 0.5 g in 1 g Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) GLYCOLIC ACID (UNII: 0WT12SX38S) HYPROMELLOSES (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score score with uneven pieces Shape ROUND Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-4681-3 0.5 g in 1 POUCH; Type 0: Not a Combination Product 01/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/30/2020 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 pack(68599-4681) Establishment Name Address ID/FEI Business Operations Allegaint Health 079501930 manufacture(68599-4681)
