ACETAMINOPHEN tablet, coated

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Bonita Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53598-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL ((Capsule Shaped Tablets))	Size	17mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53598-003-01	100 in 1 BOTTLE, PLASTIC
2	NDC: 53598-003-10	1000 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/02/2013

Labeler - Bonita Pharmaceuticals LLC (004219442)

Registrant - Bonita Pharmaceuticals LLC (004219442)

Establishment
Name	Address	ID/FEI	Business Operations
Bonita Pharmaceuticals LLC		004219442	label(53598-003)