Label: ASPIRIN 81 MG- aspirin tablet, coated
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NDC Code(s):
71335-1774-1,
71335-1774-2,
71335-1774-3,
71335-1774-4, view more71335-1774-5, 71335-1774-6, 71335-1774-7, 71335-1774-8
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 69618-066
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 25, 2024
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
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Warnings
Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.
- OTHER SAFETY INFORMATION
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SPL UNCLASSIFIED SECTION
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 steriod drug
- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
- DO NOT USE
- ASK DOCTOR/PHARMACIST
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STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you are experierance 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 more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs.
these could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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ASK DOCTOR
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
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea
- Drug Facts
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HOW SUPPLIED
NDC: 71335-1774-8: 15 Tablets in a BOTTLE
NDC: 71335-1774-1: 120 Tablets in a BOTTLE
NDC: 71335-1774-2: 30 Tablets in a BOTTLE
NDC: 71335-1774-3: 100 Tablets in a BOTTLE
NDC: 71335-1774-4: 20 Tablets in a BOTTLE
NDC: 71335-1774-5: 90 Tablets in a BOTTLE
NDC: 71335-1774-6: 60 Tablets in a BOTTLE
NDC: 71335-1774-7: 36 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 81 MG
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1774(NDC:69618-066) 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color yellow Score no score Shape ROUND Size 5mm Flavor Imprint Code 17;S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-1774-8 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 2 NDC:71335-1774-1 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 3 NDC:71335-1774-2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 4 NDC:71335-1774-3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 5 NDC:71335-1774-4 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 6 NDC:71335-1774-5 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 7 NDC:71335-1774-6 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 8 NDC:71335-1774-7 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/01/2020 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1774) , RELABEL(71335-1774)