ASPIRIN tablet, chewable

aspirin by

Drug Labeling and Warnings

aspirin by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves minor aches and pains

for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Stop use and ask a doctor if

you experience the following signs of stomach bleeding: feel faint
have bloody or black stools vomit blood
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 in the painful area
any new symptoms appear
ringing in the ears or a loss of hearing occurs

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 are taking a diuretic you have asthma you
have not been drinking fluids you have lost a lot of
fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
under a doctor’s care for any serious condition
taking any other drug

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, shock, facial swelling, asthma (wheezing)

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 nonprescritpion 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 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

Directions

 drink a full glass of water with each dose

adults and children 12 years and over:  take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

children under 12 years:  consult a doctor

Other Information

 TAMPER EVIDENT:  DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º-86ºF)

use by expiration date on package

Keep out of reach of children

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

Inactive Ingredients

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelantinized starch, sodium saccharin, stearic acid

Purpose

 temporarily relieves minor aches and pains

Principal Display Panel

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 Tablets

Principal Display Panel

Part 2 of Label

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 Tablets

Principal Display Panel

Part 3 of Label

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 Tablets

Principal Display Panel

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

1000 tablets

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6288(NDC:49483-334)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	UPPER;tcl334;LOWER;PLAIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6288-89	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2010	10/31/2020
2	NDC: 0904-6288-80	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2010	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	07/16/2010	10/31/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)