Label: EXTRA STRENGTH ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-027-30, 67046-027-60, 67046-027-62 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 10135-144
- 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 30, 2010
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 (IN EACH CAPLET)
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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DIRECTIONS
adults and children
12 years and over- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage - OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- Package Label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ACETAMINOPHEN
extra strength acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-027(NDC:10135-144) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Product Characteristics Color WHITE Score no score Shape OVAL ((capsule-shaped)) Size 17mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-027-30 30 in 1 BLISTER PACK 2 NDC:67046-027-60 60 in 1 BLISTER PACK 3 NDC:67046-027-62 60 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/02/2010 Labeler - Contract Pharmacy Services-PA (945429777)
