Label: ADULT LOW DOSE- aspirin 81 mg tablet, delayed release
-
NDC Code(s):
71309-003-01,
71309-003-02,
71309-003-05,
71309-003-10, view more71309-003-25, 71309-003-30, 71309-003-50, 71309-003-60, 71309-003-65
- Packager: Safrel Pharmaceuticals, LLC.
- 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 March 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- shock
- facial swelling
- 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
Ask a doctor before use if
- you have asthma
- 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
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
Stop use and ask a doctor 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
- an allergic reaction occurs.
Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling present in the painful area
- new symptoms occur
These could be sign of a serious condition
- Directions
- Other information
-
Inactive ingredients
Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
Compare to Bayer® Low Dose Aspirin active ingredients†
† This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer® Low Dose Aspirin.
Aspirin Enteric Coated Tablets, 81 mg
NDC 71309-003-05
NDC 71309-003-10
-
INGREDIENTS AND APPEARANCE
ADULT LOW DOSE
aspirin 81 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-003 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 CARNAUBA WAX (UNII: R12CBM0EIZ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYSORBATE 80 (UNII: 6OZP39ZG8H) BROWN IRON OXIDE (UNII: 1N032N7MFO) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71309-003-25 25 in 1 BOX 06/05/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:71309-003-50 50 in 1 BOX 06/05/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:71309-003-02 2 in 1 POUCH 06/05/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:71309-003-05 500 in 1 BOTTLE 01/09/2021 4 NDC:71309-003-01 1000 in 1 BOTTLE 4 NDC:71309-003-65 365 in 1 BOTTLE 4 NDC:71309-003-30 30 in 1 BOTTLE 4 1 in 1 CARTON; Type 0: Not a Combination Product 5 NDC:71309-003-60 1 in 1 CARTON 06/05/2017 5 60 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:71309-003-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 02/09/2016 Labeler - Safrel Pharmaceuticals, LLC. (080566287)