Label: ASPIRIN LOW DOSE- aspirin tablet
- NDC Code(s): 49638-001-01, 49638-001-02
- Packager: America Medic
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated May 16, 2012
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- ACTIVE INGREDIENT
- 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.Close
- INDICATIONS & USAGE
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.
- 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
- PRINCIPAL DISPLAY PANEL
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- INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE
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