Label: ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release
- NDC Code(s): 16103-356-09, 16103-356-11
- Packager: Pharbest Pharmaceuticals, 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 June 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- asthma (wheezing)
- facial swelling
- shock
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
if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- the 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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- gout
- diabetes
- arthritis
Stop use and ask a doctor if:
- you experience any of the following signs of stomach bleeding • feel faint •vomit blood •have bloody or black stools •have stomach pain that does not get better
- allergic reaction occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions? Adverse drug event call:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-356 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow (YELLOW COLOR) Score no score Shape ROUND (ROUND TABLET) Size 8mm Flavor Imprint Code PH023 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-356-09 1 in 1 CARTON 01/12/2007 1 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:16103-356-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 01/12/2007 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 analysis(16103-356) , manufacture(16103-356) , pack(16103-356) , label(16103-356)
