Label: REGULAR STRENGTH ENTERIC COATED ASPIRIN- aspirin tablet, coated
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NDC Code(s):
71335-0513-1,
71335-0513-2,
71335-0513-3,
71335-0513-4, view more71335-0513-5, 71335-0513-6, 71335-0513-7, 71335-0513-8
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-921
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 3, 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 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
- asthma (wheezing)
- 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 are allergic to aspirin or any other pain reliever/fever reducer
- if you ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or 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
- an allergic reaction occurs. Seek medical help right away
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in
pregnancy unless definitely directed to do so by a doctor because it may
cause problems in the unborn child or complications during delivery. -
Directions
- drink a full glass of water with each dose
- swallow whole, do not chew or crush
- do not exceed recommended dose
- adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
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Inactive ingredients
black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,
polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. - Questions or comments?
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HOW SUPPLIED
Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug.
NDC: 71335-0513-1: 30 Tablets in a BOTTLE
NDC: 71335-0513-2: 60 Tablets in a BOTTLE
NDC: 71335-0513-3: 100 Tablets in a BOTTLE
NDC: 71335-0513-4: 90 Tablets in a BOTTLE
NDC: 71335-0513-5: 20 Tablets in a BOTTLE
NDC: 71335-0513-6: 45 Tablets in a BOTTLE
NDC: 71335-0513-7: 120 Tablets in a BOTTLE
NDC: 71335-0513-8: 7 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGULAR STRENGTH ENTERIC COATED ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0513(NDC:57896-921) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM ALGINATE (UNII: C269C4G2ZQ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0513-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2019 2 NDC:71335-0513-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2021 3 NDC:71335-0513-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2019 4 NDC:71335-0513-4 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/04/2019 5 NDC:71335-0513-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/2020 6 NDC:71335-0513-6 45 in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2024 7 NDC:71335-0513-7 120 in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2020 8 NDC:71335-0513-8 7 in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/01/2000 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0513) , RELABEL(71335-0513)