ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
Physicians Total Care, Inc.

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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Active Ingredients

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

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

These could be signs 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 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.

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben


NDC 54868-2457-2

image of package label

SEE NEW WARNINGS

Non-Aspirin

Extra Strength

PAIN RELIEF

Acetaminophen Tablets

*Compare to active ingredient in Extra Strength Tylenol Tablets

PACKAGE NOT CHILD RESISTANT

500 mg each

Dist. By: Gericare Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146



ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2457(NDC:57896-201)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (UNII: 68401960MK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (Round) Size12mm
FlavorImprint Code M2A457344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2457-2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/22/2002
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 1/2012
Document Id: 902526fc-a17b-481a-98bd-fe9f63a7742d
Set id: 33376625-3cc2-4bf2-9009-a3e728f4b8f5
Version: 1
Effective Time: 20120124
 
Physicians Total Care, Inc.