MICRO-COATED ASPIRIN 325 MG- aspirin tablet, coated

MICRO-COATED ASPIRIN 325 mg by

Drug Labeling and Warnings

MICRO-COATED ASPIRIN 325 mg by is a Otc medication manufactured, distributed, or labeled by MAJOR PHARMACEUTICALS, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscle pain
• toothache
• menstrual pain
• colds
• minor pain of arthritis
• temporarily reduces fever

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include

• hives
• facial swelling
• asthma (wheezing)
• shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis or kidney disease
• you have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away
• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• ringing in the ears or loss of hearing occurs
• any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.  

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• drink a full glass of water with each dose

• adults and children 12 years and over: take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: consult a doctor

Other information

• store at room temperature. Excursions permitted between 150-300C. Avoid excessive heat above 40oC
• Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

corn starch, hypromellose, microcrystalline cellulose, stearic acid, talc, triacetin

Questions or comments?

(800) 616-2471

PRINCIPAL DISPLAY PANEL

COMPARE TO GENUINE BAYER®ASPIRIN ACTIVE INGREDIENT**

NDC: 0904-6811-80

MICRO-COATED

ASPIRIN

325 mg

PAIN RELIEVER

FEVER REDUCER

(NSAID)

FAST, SAFE PAIN RELIEF

1000 Coated Tablets

MAJOR®

INGREDIENTS AND APPEARANCE

MICRO-COATED ASPIRIN 325 MG 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6811
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH041
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6811-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	12/18/2018

Labeler - MAJOR PHARMACEUTICALS (191427277)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)