aspirin by Safecor Health, LLC DRUG FACTS

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-303(NDC: 49483-334)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	UPPER;tcl334;LOWER;PLAIN
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 48433-303-01	1 in 1 POUCH; Type 0: Not a Combination Product	09/30/2014	11/13/2019
2	NDC: 48433-303-10	100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	09/30/2014	11/13/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/30/2014	11/13/2019

Labeler - Safecor Health, LLC (828269675)

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

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		078805287	REPACK(48433-303)

Revised: 11/2019

Document Id: dfe125a1-6c52-4dc4-a8b7-28ea04b25f4f

Set id: 97bf4e39-e53b-42fe-b770-03a0f568cff5

Version: 2

Effective Time: 20191113

Safecor Health, LLC