FDA.reportPublic FDA data

bio vanta (NSAID*) Dual Action Throat Spray

Manufacturer
Applied Biological Laboratories Inc.
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:18:07

Label at a glance#

ProductBiovanta Double Action
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

■ 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Do Not Use

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

■ 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73678-16073678-160-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOEV5VD430YW9IACT
SORBIC ACIDX045WJ989BIACT
MENTHOLL7T10EIP3AIACT
LACTOFERRIN, BOVINEKG21X1090AIACT
LYSOZYME968JKA7T33IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ASPIRINR16CO5Y76EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c918986-e983-70b6-e063-6394a90a7fecad34559a-1a0f-693d-e053-2995a90ae70a2023-12-15WarningsExact identifier
spl id: 0c918986-e983-70b6-e063-6394a90a7fec
spl set id: ad34559a-1a0f-693d-e053-2995a90ae70a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.