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Aspirin Low Dose by America Medic

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: America Medic
NDC Code: 49638-001

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.

Drug facts


Aspirin

Internal Analgesic.

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

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


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.


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.

Yellow # 10

Yellow # 6

Methacrylic Acid Copolymer

Microcrystalline Cellose

Stearic Acid

Titanium Dioxide

Triethyl Citrate

Image of carton

ASPIRIN  LOW DOSE
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
Coloryellow (yellow ) Scoreno score
ShapeROUND (tablet) Size6mm
FlavorImprint CodeC3
Contains    
Packaging
#Item CodePackage Description
1NDC:49638-001-021 BOTTLE (BOTTLE) in 1 CARTON
1NDC:49638-001-01120 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/15/2012
Labeler - America Medic (071065464)
Establishment
NameAddressID/FEIOperations
America Medic071065464relabel, repack
Establishment
NameAddressID/FEIOperations
Cispharma Inc.833171445manufacture

Revised: 05/2012
 
America Medic

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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