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ACETAMINOPHEN EXTRA STRENGTH by TIME CAP LABS INC

Medically reviewed on July 18, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: TIME CAP LABS INC
NDC Code: 49483-341

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.

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.


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ACETAMINOPHEN   EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeTCL341
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-341-01100 TABLET, FILM COATED (TABLET) 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/FEIOperations
TIME CAP LABS INC037052099manufacture

 
TIME CAP LABS 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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