Label: ASPIRIN ADULT LOW DOSE- acetylsalicyclic acid tablet, delayed release
- NDC Code(s): 53329-985-67
- Packager: Medline Industries, LP
- 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.
Drug Label Information
Updated August 31, 2022
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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
- 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
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
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
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
- an allergic reaction occurs. Seek medical help right away.
- if you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs.
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
ASPIRIN ADULT LOW DOSE
acetylsalicyclic acid tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-985 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARNAUBA WAX (UNII: R12CBM0EIZ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color yellow Score score with uneven pieces Shape ROUND Size 7mm Flavor Imprint Code embossed;heart Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-985-67 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/25/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/25/2018 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)