Label: BIOVANTA DOUBLE ACTION- acetylsalicylic acid spray
- NDC Code(s): 73678-160-02
- Packager: Applied Biological Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Drug Facts
- Active ingredient
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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:
- asthma (wheezing)
- hives
- facial swelling
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (e.g. aspirin, ibuprofen, naproxen, or others)
- takes more than directed or for a longer time than directed
- is age 60 or older
- has 3 or more alcoholic drinks every day while using this product
Do Not Use
Do not use:
- if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems, unless directed by a doctor
- If allergic to milk and/or egg white, or have ever had an allergic reaction to this product or any of its ingredients.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult your healthcare provider.
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INGREDIENTS AND APPEARANCE
BIOVANTA DOUBLE ACTION
acetylsalicylic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73678-160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 6 mg in 0.1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) SORBIC ACID (UNII: X045WJ989B) MENTHOL (UNII: L7T10EIP3A) LACTOFERRIN, BOVINE (UNII: KG21X1090A) LYSOZYME (UNII: 968JKA7T33) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73678-160-02 1 in 1 BOX 08/15/2020 12/31/2024 1 5 mL in 1 BOTTLE, SPRAY; 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 08/15/2020 12/31/2024 Labeler - Applied Biological Laboratories Inc. (080512733)
