Acetaminophenextra strength tablet
Spl unclassified section
*Compared to the active ingredient in Extra Strength Tylenol ®
(in each tablet)
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
For the temporary relief of minor aches and pains due to:
- Muscular aches
- Minor pain of arthritis
- The common cold
- Premenstrual and menstrual cramps
Temporarily reduces fever.
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 haveliver disease.
Ask a doctor or pharmacist before use if you aretaking 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.
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.
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.
- Store at room temperature 15-30C (59-86F)
- Use by expiration date on package
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®.
104 Hippocrates Way,
Glasgow, KY 42141
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Otc - keep out of reach of children section
Keep out of reach of children.
Ingredients and appearance - Product information
Acetaminophenextra strength tablet- Acetaminophen
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 54868-3832|
|Route of Administration||Oral|
|Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D )||500 mgin 1|
|Povidone||( UNII: FZ989GH94E)|
|Starch, corn||( UNII: O8232NY3SJ)|
|Sodium starch glycolate type a potato||( UNII: 5856J3G2A2)|
|Stearic acid||( UNII: 4ELV7Z65AP)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC monograph final||part343||USA|
Labeler - Physicians Total Care, Inc.( 194123980)
|Physicians Total Care, Inc.||194123980||relabel( 54868-3832)|
Package label.principal display panel