ASPIRIN LOW DOSE- aspirin tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by America Medic, Cispharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin

PURPOSE

Internal Analgesic.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Oral Analgesic. Aspirin is not appropriate for everyone, so be sure to talk to a doctor before starting an Aspirin regimen.

WARNINGS

Do not use this product if you are allergic to Aspirin or any other pain/fever product.
If pregnant or breastfeeding contact a doctor before using.
Contact a doctor or pharmacist if you are taking a prescription drug for-Gout, Diabetes or Arthritis.
Contact a doctor right away if: An allergic reaction occurs.

DOSAGE & ADMINISTRATION

Drink a full glass of water with each dose.
Adults and children 12 years of age and up:Take 4-8 tablets every 4 hours not to exceed 48 tablets in 24hours unless indicated by a doctor.. Children under 12 years of age : Consult a Doctor.

INACTIVE INGREDIENT

Yellow # 10

Yellow # 6

Methacrylic Acid Copolymer

Microcrystalline Cellose

Stearic Acid

Titanium Dioxide

Triethyl Citrate

PRINCIPAL DISPLAY PANEL

Image of carton

INGREDIENTS AND APPEARANCE

ASPIRIN  LOW DOSE
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49638-001
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow (yellow )	Score	no score
Shape	ROUND (tablet)	Size	6mm
Flavor		Imprint Code	C3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49638-001-02	1 in 1 CARTON
1	NDC: 49638-001-01	120 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/15/2012

Labeler - America Medic (071065464)

Establishment
Name	Address	ID/FEI	Business Operations
America Medic		071065464	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Cispharma Inc.		833171445	manufacture