ACETAMINOPHEN - 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.

----------

Acetaminophen Tablets

*Compared to the active ingredient in Tylenol®

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 325 mg

PURPOSES

Pain Reliever/Fever Reducer

USES

for the temporary relief of minor aches and pains due to:

Temporarily reduces fever.

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

Do not use

Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is 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.

Keep out of reach of children.

Keep out of reach of children.

OVERDOSAGE

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.

DIRECTIONS

Do not take more than directed

AgeDose
Adults and Children 12
years and over
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
Children 6-11 years
  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

OTHER INFORMATION

INACTIVE INGREDIETNS

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


Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK       74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Tablets

325 mg

Bottles of 50
NDC 54868-0548-2
Bottles of 100
NDC 54868-0548-4
Bottles of 1000
NDC 54868-0548-3
image of 325 mg package label


ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0548(NDC:65162-350)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize4mm
FlavorImprint Code GPI;A325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-0548-250 in 1 BOTTLE
2NDC:54868-0548-31000 in 1 BOTTLE
3NDC:54868-0548-4100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/24/2002
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 12/2009
Document Id: afda5f51-4b06-44ef-b730-be5a86ffb097
Set id: bb2975ce-2330-4922-b5ea-ad86a979fbab
Version: 2
Effective Time: 20091216
 
Physicians Total Care, Inc.