Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 12634-111-01, 12634-111-10, 12634-111-60, 12634-111-74, view more12634-111-91 - Packager: Apotheca, Inc
- This is a repackaged label.
- Source NDC Code(s): 16103-353
- 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 July 29, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS: ACTIVE INGREDIENT
- USES
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
do not take more then directed
adults and children 12 years and over
take 1 to 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
children 6 to under 12 years
take 1 tablet every 4 to 6 hours as needed. Do not take nore than 5 tablets in 24 hours
children under 6 years
consult a doctor. Do not use this adult regular strength product in children under 6 years of age, this will provide more than the recommended dose (overdose) acetominophen and may cause liver damage.
Tamper Evident: do not use if imprinted safety seal under cap is broken or missingStore between 20-25oC (68-77oF)Use by expiration date on packageTo report adverse drug events call 1-800-332-1088
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WARNINGS
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing acetaminophen
- Adult has 3 or more alcoholic drinks every day while using this product
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
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 use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
These could be sign of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.
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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 while symptoms last.
Do not take more than 12 tablets in 24 hours.Children 6 to under 12 years
Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.Children under 6 years
Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Other information
- Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
- store between 20-25°C (68-77°F)
- use by expiration date on package
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12634-111(NDC:16103-353) 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 POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STARCH, POTATO (UNII: 8I089SAH3T) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code PH020 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12634-111-74 24 in 1 BOTTLE 2 NDC:12634-111-60 60 in 1 BOTTLE 3 NDC:12634-111-01 100 in 1 BOTTLE 4 NDC:12634-111-10 1000 in 1 BOTTLE 5 NDC:12634-111-91 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/1996 Labeler - Apotheca, Inc (051457844) Establishment Name Address ID/FEI Business Operations Apotheca, Inc 051457844 relabel(12634-111)
