Label: ASPIRIN tablet, delayed release
- NDC Code(s): 73376-001-50
- Packager: INVAHEALTH INC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 8, 2024
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- ACTIVE INGREDIENT
- PURPOSE
-
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 problem
- take a blood thinning (anticoagulant) or steroid drug
- take other drug 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
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
-
PREGNANCY OR BREAST FEEDING
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 right away. - DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- QUESTIONS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73376-001 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 FD&C YELLOW NO. 6 (UNII: H77VEI93A8) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code I1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73376-001-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/10/2022 Labeler - INVAHEALTH INC (116840615)