Label: ASCURIN FAST ACTION- aspirin powder
- NDC Code(s): 83607-001-00
- Packager: HealthDoc LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each sachet)
- Use
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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)
■ ShockStomach 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 directedDo not use
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ for at least 7 days after tonsillectomy or oral surgery unless directed by a doctorAsk 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 asthmaAsk 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
■ 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
■ any new symptoms occur
■ ringing in the ears or loss of hearing occurs -
Directions
■ Adults: Drink a full glass of water with each dose.
■ Adults and children 12 years and over: Take 5-8 sachets every 4 hours not to exceed 49 sachets in 24 hours unless directed by a doctor.
■ Children under 12 years of age: consult a doctor.
■ See your doctor for other uses of aspirin, but do not use for more than 10 days without consulting your doctor because serious side effects may occur. - Other information
- Inactive ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ASCURIN FAST ACTION
aspirin powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83607-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg in 2 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CURCUMIN (UNII: IT942ZTH98) MALIC ACID (UNII: 817L1N4CKP) NEOTAME (UNII: VJ597D52EX) ORANGE OIL (UNII: AKN3KSD11B) POVIDONE K30 (UNII: U725QWY32X) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83607-001-00 28 in 1 BOX 10/23/2023 1 2 g in 1 POUCH; 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 10/23/2023 Labeler - HealthDoc LLC (013084196)
