NDC | 71309-103-01, 71309-103-02, 71309-103-25, 71309-103-30, 71309-103-50, 71309-103-60, 71309-103-65 |
Set ID | 87401db3-7162-b48b-e053-2a95a90ac98f |
Category | HUMAN OTC DRUG LABEL |
Packager | Safrel Pharmaceuticals, LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active Ingredients (in each tablet) Purpose
Aspirin 81 mg (NSAID)* ........................................ Pain reliever
*nonsteroidal anti-inflammatory drug
- Uses
- temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
- ask your doctor about other uses for 81 mg Aspirin
- 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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
- Other information
- store at room temperature 15-30ºC (59-86ºF)
- read all product information before using.
- Keep this box for important information
-
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- 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
Close - 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 Delayed Release Tablets, 81 mg
- INGREDIENTS AND APPEARANCE
ADULT LOW DOSE
aspirin 81 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-103 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) BROWN IRON OXIDE (UNII: 1N032N7MFO) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) 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:71309-103-25 25 in 1 BOX 06/05/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:71309-103-50 50 in 1 BOX 06/05/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:71309-103-02 2 in 1 POUCH 06/05/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:71309-103-01 1000 in 1 BOTTLE 06/05/2017 4 NDC:71309-103-65 365 in 1 BOTTLE 4 NDC:71309-103-30 30 in 1 BOTTLE 4 1 in 1 CARTON; Type 0: Not a Combination Product 5 NDC:71309-103-60 1 in 1 CARTON 06/05/2017 5 60 in 1 BOTTLE; Type 0: Not a Combination Product 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)