ACETAMINOPHEN  - acetaminophen tablet 
TIME CAP LABS INC

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 Type HUMAN OTC DRUG NDC Product Code (Source) 49483-340 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg

Inactive Ingredients Ingredient Name Strength POVIDONE   STARCH, CORN   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID

Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL340 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-340-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/15/2011

Labeler - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABS INC		037052099	manufacture

Revised: 12/2011TIME CAP LABS INC