PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet 
Amerisource Bergen

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.

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DRUG FACTS

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if you take:

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.

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: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to TYLENOL® Extra Strength active ingredient †

Extra Strength

PAIN RELIEVER

ACETAMINOPHEN 500 mg

pain reliever/ fever reducer

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®

Product Label

Good Neighbor Pharmacy

Acetaminophen 500 mg

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-178
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code TCL252
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46122-178-72 1 in 1 BOX
1 60 in 1 BOTTLE
2 NDC:46122-178-78 1 in 1 BOX
2 100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 11/08/2011
Labeler - Amerisource Bergen (007914906)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 725a7684-d0b3-467f-bcab-762f52f7d74d
Set id: 5dffb278-f92b-43e0-8558-f9668446f10b
Version: 1
Effective Time: 20121226
 
Amerisource Bergen