Label: ASPIRIN LOW DOSE ENTERIC COATED- aspirin tablet
- NDC Code(s): 49483-390-00
- Packager: Time-Cap Labs, Inc
- 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.
Drug Label Information
Updated December 17, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate - PURPOSE
- DOSAGE & ADMINISTRATION
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ASK DOCTOR
Ask a doctor before use if • stomach bleeding warning
applies to you • you have a history of stomach
problems, such as heartburn • you have high blood
pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic • you have asthma • you
have not been drinking fluids • you have lost a lot of
fluid due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug - ASK DOCTOR/PHARMACIST
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PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before
use. It is especially important not to use aspirin during the last
3 months of pregnancy unless definitely directed to do so by a
doctor because it may cause problems in the unborn child or
complications during delivery.
Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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 serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:hives
facial swelling
shock
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
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE ENTERIC COATED
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-390 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code embossed;A;lower;plain Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-390-00 100000 in 1 CARTON; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 07/16/2010 Labeler - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-390)