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Acetaminophen by Bonita Pharmaceuticals LLC

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Bonita Pharmaceuticals LLC
NDC Code: 53598-003

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.

Extra Strength Acetaminophen 500mg Caplets

Active Ingredient

(in each caplet)

Acetaminophen 500mg

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 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000mg 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 nonprescription). 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 pressent

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 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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

Children under 12years: 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 (855) 729-7200.

PRINCIPAL DISPLAY PANEL

Image 1 : Extra Strength Acetaminophen 500mg, 1000ct caplets

Image 2 : Extra Strength Acetaminophen 500mg, 100ct caplets

ACETAMINOPHEN 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL ((Capsule Shaped Tablets)) Size17mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:53598-003-01100 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:53598-003-101000 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/02/2013
Labeler - Bonita Pharmaceuticals LLC (004219442)
Registrant - Bonita Pharmaceuticals LLC (004219442)
Establishment
NameAddressID/FEIOperations
Bonita Pharmaceuticals LLC004219442label(53598-003)

Revised: 04/2013
 
Bonita Pharmaceuticals LLC

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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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