Label: ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable
- NDC Code(s): 49483-334-00, 49483-334-19, 49483-334-63
- Packager: Time-Cap Labs, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 17, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- INDICATIONS & USAGE
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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
- 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
- this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
- if you have ever had an allergic reaction to this product or any of its ingredients
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
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
- vomit blood
- have bloody or black stools
- 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 - STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE CHEWABLE
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-334 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) ORANGE (UNII: 5EVU04N5QU) STARCH, CORN (UNII: O8232NY3SJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code UPPER;tcl334;LOWER;PLAIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-334-63 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-334-00 100000 in 1 CARTON; Type 0: Not a Combination Product 12/17/2018 3 NDC:49483-334-19 3 in 1 CARTON 04/19/2024 3 36 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 Drug M013 07/16/2010 Labeler - Time-Cap Labs, Inc (037052099) Registrant - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-334)
