Label: ENTERIC COATED ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release
-
NDC Code(s):
71335-0157-1,
71335-0157-2,
71335-0157-3,
71335-0157-4, view more71335-0157-5, 71335-0157-6, 71335-0157-7, 71335-0157-8
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 49483-331
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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 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
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
-
INACTIVE INGREDIENT
Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
- QUESTIONS
-
HOW SUPPLIED
NDC: 71335-0157-1: 30 Tablets in a BOTTLE
NDC: 71335-0157-2: 60 Tablets in a BOTTLE
NDC: 71335-0157-3: 100 Tablets in a BOTTLE
NDC: 71335-0157-4: 90 Tablets in a BOTTLE
NDC: 71335-0157-5: 20 Tablets in a BOTTLE
NDC: 71335-0157-6: 45 Tablets in a BOTTLE
NDC: 71335-0157-7: 120 Tablets in a BOTTLE
NDC: 71335-0157-8: 7 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ENTERIC COATED ASPIRIN REGULAR STRENGTH
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0157(NDC:49483-331) 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 STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0157-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 2 NDC:71335-0157-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 3 NDC:71335-0157-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/19/2018 4 NDC:71335-0157-4 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 5 NDC:71335-0157-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 6 NDC:71335-0157-6 45 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 7 NDC:71335-0157-7 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 8 NDC:71335-0157-8 7 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/04/2011 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0157) , RELABEL(71335-0157)