Label: ACETAMINOPHEN tablet
- NDC Code(s): 49483-340-01, 49483-340-10
- Packager: TIME CAP LABS 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 March 28, 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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
• rashIf a skin reaction occurs, stop use and seek medical help right away.
- DO NOT USE
- 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.
See overdose warning
adults and children 12 years and over
• take 2 tablets every 4 to 6 hours while symptoms last
• do not take more than 10 tablets in 24 hours, unless directed by a doctor
• do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
• take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours
• do not use for more than 5 days unless directed by a doctor
children under 6 years
• ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-340 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL340 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-340-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-340-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/15/2011 Labeler - TIME CAP LABS INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABS INC 037052099 manufacture(49483-340)