Label: CETAFEN EXTRA- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50332-0108-1, 50332-0108-3, 50332-0108-4, 50332-0108-7, view more50332-0108-8 - Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
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 November 11, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- 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 a Poison Control Center right away. 1-800-222-1222.
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DOSAGE & ADMINISTRATION
Directions: do not take more than directed
- Adults and children 12 years of age and over:
- take 2 caplets every 4 to 6 hours while symptoms persist
- do not take more than 8 caplets in 24 hours unless directed by a doctor
Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETAFEN EXTRA
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0108 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 HYDROXYPROPYL METHYLCELLULOSE E5 [II] (UNII: R75537T0T4) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code CFNX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0108-3 20 in 1 BOX, UNIT-DOSE 1 2 in 1 PACKET 2 NDC:50332-0108-4 50 in 1 BOX, UNIT-DOSE 2 2 in 1 PACKET 3 NDC:50332-0108-7 125 in 1 BOX, UNIT-DOSE 3 2 in 1 PACKET 4 NDC:50332-0108-8 250 in 1 BOX, UNIT-DOSE 4 2 in 1 PACKET 5 NDC:50332-0108-1 400 in 1 BOX, UNIT-DOSE 5 2 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/05/1990 Labeler - HART Health (069560969)