Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-3832-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 65162-607
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 24, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSES
- USES
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WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets 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
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
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In the 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
Do not take more than directed.
Adults and children 12 years and over:
- Take 2 caplets every 4 to 6 hours while symptoms last
- Do not take more than 8 caplets in 24 hours
- Do not take for more than 10 days unless directed by a doctor
Children under 12 years:
- Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
- OTHER INFORMATION
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INACTIVE INGREDEINTS
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid
Questions? To report a Serious Adverse Event contact 1-877-835-5472.
*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol®.
Distributed by:
Amneal Pharmaceuticals
104 Hippocrates Way,
Glasgow, KY 42141
Rev. 11/2009
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3832(NDC:65162-607) 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 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 CAPSULE Size 6mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-3832-0 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 10/24/2002 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-3832)
