Label: ACETAMINOPHEN tablet, coated
- NDC Code(s): 49035-869-50
- Packager: WAL-MART STORES 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 February 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 4 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.
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
do not take more than directed.
adults and children 12 years and over:
take 2 caplets (1,000 mg) every 6 hours while symptoms last
do not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctordo not use more than 10 days unless directed by a doctor
children under 12 years:ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
-
DO NOT 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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-869 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 HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white Score no score Shape OVAL (caplet) Size 17mm Flavor Imprint Code TCL341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-869-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/01/2020 Labeler - WAL-MART STORES INC (051957769) Registrant - TIME CAP LABORATORIES INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(49035-869)
