Aspirinlow dose chewable tablet, chewable

Active ingredients

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

Otc - keep out of reach of children section


Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

Inactive ingredient section

Inactive ingredients: bht, dextrates, FD-C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid

Otc - purpose section

PURPOSE: Pain reliever

Indications & usage section

Usestemporarily 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

Dosage & administration section

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

Warnings section

WARNINGS:
Reyes 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 Reyes syndrome, a rare but serous Illinois.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, 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 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.

Ingredients and appearance - Product information

Aspirinlow dose chewable tablet, chewable- Aspirin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 48433-303
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Aspirin ( UNII: R16CO5Y76E)( Aspirin - UNII: R16CO5Y76E ) 81 mgin 1

Inactive Ingredients

Ingredient Name Code
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Dextrates ( UNII: G263MI44RU)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Modified corn starch (1-octenyl succinic anhydride) ( UNII: 461P5CJN6T)
Orange ( UNII: 5EVU04N5QU)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Saccharin sodium ( UNII: SB8ZUX40TY)

Product Characteristics

Color orange Size 8 mm
Shape ROUND Score 1
Imprint Code UPPER;tcl334;LOWER;PLAIN

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - Safecor Health, LLC( 828269675)

Establishment

Name ID/FEI Business Operations
Safecor Health, LLC 828269675 REPACK( 48433-303)

Package label.principal display panel