Label: CETAFEN- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50332-0103-1, 50332-0103-4, 50332-0103-7, 50332-0103-8 - Packager: HART Health
- 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 August 11, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
- rash
- blisters
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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OVERDOSAGE
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact Poison Control Center right away. 1-800-222-1222
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETAFEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0103 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code CFN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0103-4 50 in 1 BOX, UNIT-DOSE 06/04/1986 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50332-0103-7 125 in 1 BOX, UNIT-DOSE 06/04/1986 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:50332-0103-8 250 in 1 BOX, UNIT-DOSE 06/04/1986 3 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:50332-0103-1 500 in 1 BOX, UNIT-DOSE 06/04/1986 4 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/04/1986 Labeler - HART Health (069560969)