aspirin by Safecor Health, LLC DRUG FACTS

aspirin by

Drug Labeling and Warnings

aspirin by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable 
Safecor Health, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENTS

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


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

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

PURPOSE:  Pain reliever

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

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: 
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 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.

Chewable Aspirin 81 mg Robot Unit Dose Box Label
ASPIRIN  LOW DOSE CHEWABLE
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 48433-303(NDC: 49483-334)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code UPPER;tcl334;LOWER;PLAIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 48433-303-011 in 1 POUCH; Type 0: Not a Combination Product09/30/201411/13/2019
2NDC: 48433-303-10100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product09/30/201411/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/30/201411/13/2019
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(48433-303)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287REPACK(48433-303)

Revised: 11/2019
 
Safecor Health, LLC