ACETAMINOPHEN  - acetaminophen tablet 
TIME CAP LABS 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 ingredient (in each tablet)

ACETAMINOPHEN 500 MG

POVIDONE,PREGELATINIZED STARCH, STEARIC ACID

PAIN RELIEVER/FEVER REDUCER

LIVER WARNING:  THIS PRODUCT CONTAINS ACETAMINOPHEN.  SEVERE LIVER DAMAGE MAY OCCUR IF YOU TAKE:

More than 8 tablets 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.

USES;

Temporarily relieves minor aches and pains due to:  The common cold; backache; minor pain of arthritis; muscular aches;premenstrual cramps;temporarily reduces fever; headache;toothache

DO NOT USE: With other drugs containing acetaminophen(prescription or non prescription).  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 last more than 3 days, new symptoms occur; redness or swelling is present; these could be signs of a serious condition.

DIRECTIONS;

DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)

Adults and children 12 years and over:  take 2 tablets every 4-6 hours while symptoms last

Do not take more than 8 tablets in 24 hours

Do not use for more than 10 days unless directed by a doctor

Children under 12 years : do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Keep out of the reach of children

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 was well as children even if you do not notice any signs or symptoms.


If pregnant or breast-feeding, ask a health professional before use.

100label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-252
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScore no score
ShapeROUNDSize12mm
FlavorImprint Code TCL252
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:49483-252-01100 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/12/2011

Labeler - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABS INC037052099manufacture

Revised: 07/2011 TIME CAP LABS INC