Label: ASPIRIN tablet, coated
Contains inactivated NDC Code(s)
NDC Code(s): 0440-1130-90
- Packager: Liberty Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49483-011
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 5, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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
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, 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
- DO NOT USE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0440-1130(NDC:49483-011) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 ng Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0440-1130-90 90 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 04/18/2012 Labeler - Liberty Pharmaceuticals, Inc. (012568840)