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ACETAMINOPHEN by TIME CAP LABS INC

Medically reviewed on December 15, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: TIME CAP LABS INC
NDC Code: 49483-340

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.

DRUG FACTS

Active ingredient (in each tablet)
Acetaminophen 325 mg

Purpose
Pain reliever/fever reducer

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

Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you have:
  • 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

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
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.

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 (1-800-222-1222) right away. 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 (see overdose 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 ng) 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 (overdose) of acetaminophen and may cause liver damage

Other information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient

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ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-340
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL340
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-340-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/15/2011
Labeler - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABS INC037052099manufacture

 
TIME CAP LABS INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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