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ACETAMINOPHEN by TIME CAP LABORATORIES, INC

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-342

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 500 mg


PURPOSE:  Pain Reliever - fever reducer

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

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

Warnings;
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; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage.  in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.



Do not take more than directed (see overdosage warning)

Adults and children 12 years and over:  take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; 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 dose (overdosage) of acetaminophen and may cause liver damage



CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE



** MAY CONTAIN THIS INGREDIENT

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-342
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FD&C RED NO. 40 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 8000 
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeTCL342
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-342-01100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-342-101000 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
3NDC:49483-342-00100000 TABLET, FILM COATED (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/01/2012
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC037052099manufacture

Revised: 05/2012
 
TIME CAP LABORATORIES, INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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