Biovanta Trip Action Green Apple and Honey

Manufacturer
Applied Biological Laboratories Inc. | Lozy's Pharmaceuticals SL.
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:10:18

Label at a glance#

ProductBiovanta Trip Action Green Apple and Honey
Active ingredientASPIRIN, MENTHOL
Label structure15 sections

Indications and uses

■ Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. ■ For the temporary relief of minor aches and pains associated with a sore throat.

Dosage and administration

• Dissolve1 lozenge slowly in mouth. • Repeat every half hour as needed or as directed by health care provider. • Children under 6 consult health care provider.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each lozenge):

OTC - ACTIVE INGREDIENT SECTION

Menthol 5mg......Antitussive

Acetyl Salicylic Acid* (NSAID)* 6 mg.......Analgesic

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Antitussive and Analgesic

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.
■ 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:

■ hashad stomach ulcers or bleeding problems
■ takes a blood thinning (anticoagulant) or steroid drug
■ takes other drugs containing prescription or nonprescription NSAl□s (e.g. aspirin, ibuprofen, naproxen, or others)
■ takes more than directed or for a longer time than directed
■ is age60 or older
■ has 3 or more alcoholic drinks per day while using this product

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a history of stomach problems, such as heartburn
■ high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ taken a diuretic ■ not been drinking fluids ■ lost a lot of fluid due to vomiting or diarrhea

Stop use

OTC - STOP USE SECTION

Stop use of this product and ask a healthcare provider if user experiences any of the lollowing signs or stomach bleeding:

feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better

Pregnancy

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy: If pregnant or breast-feeding, always ask your healthcare provider before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor as it may cause problems in the unborn child or complications during delivery.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

• Dissolve1 lozenge slowly in mouth.
• Repeat every half hour as needed or as directed by health care provider.
• Children under 6 consult health care provider.

Other Information

OTHER SAFETY INFORMATION

■ Store at room temperature.
■ Check expiration date before using.
■ Tamper Evident: Do not use if imprinted shrink band is broken or missing.
■ Do not give lozenges to children younger than age 4.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe, Honey, lsomalt, Lactoferin, Lysozyme, Natural Colors, Natural Apple Flavor, Stevia Rebaudiana, Sodium Chloride, Water

biovanta Lemon & Honey

SPL UNCLASSIFIED SECTION

biovanta™

(NSAID*)

TRIPLE ACTION

SOOTHES SORE THROATS.

FIGHTS COLDS & COUGH.

Natural Bioactive Ingredients

Green Apple & Honey

24 Lozenges

NDC 73678-260-24

Distributed by:

Applied Biological Laboratories

760 Parkside Ave.

317, 327-D and 327-F

Brooklyn, New York 11226

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73678-260-242022-02-01C16284748780-1d6a99b39-4700-a426-e053-dadaa90af4c2biovanta Green Apple & Honey
73678-260-242022-01-28C16284748780-1d6a99b39-4700-a426-e053-dadaa90af4c2biovanta Green Apple & Honey

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
73678-26073678-260-24

Ingredients#

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

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

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
d6faeafd-9bfc-48c1-e053-2a95a90a9796ae715d37-6178-2324-e053-2a95a90a166b2022-02-01WarningsExact identifier
spl id: d6faeafd-9bfc-48c1-e053-2a95a90a9796
spl set id: ae715d37-6178-2324-e053-2a95a90a166b

Reported adverse events (FAERS/openFDA)#

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