DrugCite

ACETAMINOPHEN - acetaminophen tablet, coated 
Bonita Pharmaceuticals LLC

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

Extra Strength Acetaminophen 500mg, 1000ct caplets

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

Extra Strength Acetaminophen 500mg, 100ct caplets

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


ACETAMINOPHEN 
acetaminophen  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 53598-003
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, PREGELATINIZED CORN  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
Product Characteristics
Color white Score no score
Shape OVAL ((Capsule Shaped Tablets)) Size 17mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 53598-003-01 100  In 1 BOTTLE, PLASTIC None
2 53598-003-10 1000  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 04/02/2023

Labeler - Bonita Pharmaceuticals LLC (004219442)
Registrant - Bonita Pharmaceuticals LLC (004219442)
Establishment
Name Address ID/FEI Operations
Bonita Pharmaceuticals LLC 004219442 label
Revised: 04/2013Bonita Pharmaceuticals LLC