Label: ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release
- NDC Code(s): 72789-039-01, 72789-039-35, 72789-039-98
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16103-356
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 8, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72789-039(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:72789-039-98 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2019 2 NDC:72789-039-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2020 3 NDC:72789-039-35 35 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/12/2007 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(72789-039)
