Your browser does not support JavaScript! ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]
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ACETAMINOPHEN (acetaminophen) tablet, film coated
[TIME CAP LABS INC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient (in each tablets

acetaminophen 500 mg


Inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

PAIN RELIEVER - FEVER REDUCER

Warning:  Liver Warning:  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

Uses:  temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps, temporarily reduces fever.

Ask a doctor before use if you have liver disease.

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.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Keep out of reach of children

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

Directions:  Do not take more than directed (see overdose warning)

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 this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.


100labelEnter section text here

ACETAMINOPHEN   EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49483-341
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MINERAL OIL 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code TCL341
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-341-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/18/2011
Labeler - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS INC037052099manufacture

Revised: 7/2011
 
TIME CAP LABS INC

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