Acetaminophen PAIN RELIEVER,FEVER REDUCER 500 Mg: Package Insert and Label Information

ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet
Medsouce Pharmaceuticals

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 tablet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses

  • for the temporary relief of minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 every 6 hours while symptoms last
  • do not take more than 6 tablets 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: ask a doctor.

Other information

  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

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APAP Tablets 500 mg
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ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER 500 MG
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-136(NDC:51645-706)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND (round flat faced beveled edge) Size 12mm
Flavor Imprint Code GPI;A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-136-30 30 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 10/01/2020
Labeler — Medsouce Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-136)

Revised: 10/2020 Medsouce Pharmaceuticals

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