BIOVANTA DOUBLE ACTION- acetylsalicylic acid spray

Biovanta Double Action by

Drug Labeling and Warnings

Biovanta Double Action by is a Otc medication manufactured, distributed, or labeled by Applied Biological Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each dosage)Acetyl Salicylic Acid* (NSAID) 6mg*

Purpose

Analgesic

Uses

For the temporary relief of minor aches and pains associated with a sore throat.

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

Pregnancy

If pregnant or breast-feeding, always ask your healthcare provider before use.

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.

Keep Out of Reach of Children

Children Warning:Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Apply one spray of Step1 and one spray of Step2 to the affected area. Apply as needed - no more than once every 30 minutes.
• Once mixed, do not use after 90 days.

Other Information

■ Store at room temperature.
■ Check unmixed product expiration date. Once mixed, fill in activation date on spray label watermark area. Do not use after 90 days after activation.
■ Tamper Evident:Do not use if imprinted shrink band is broken or missing.

Inactive Ingredients

Aloe, Ethanol, Glycerin, Lactoferrin, Lysozyme, Menthol, Propylene Glycol, Sodium Chloride, Sorbic Acid, Water

SPL UNCLASSIFIED SECTION

bio vanta

(NSAID*)

DUAL ACTION THROAT SPRAY

• Relieves Sore Throats
• Fights Colds

Mix to Activate

5 ml bottle / 0.1 mL per spray

NDC: 73678-160-02

Questions or Comments? 866-889-3959

info@appliedbioinc.com

Distributed by:

Applied Biological Laboratories

760 Parkside Ave., 317

Brooklyn, New York 11226

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOVANTA DOUBLE ACTION 
acetylsalicylic acid spray

Product 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)