biovanta Green Apple & Honey

Biovanta Trip Action Green Apple and Honey by

Drug Labeling and Warnings

Biovanta Trip Action Green Apple and Honey by is a Otc medication manufactured, distributed, or labeled by Applied Biological Laboratories Inc., Lozy's Pharmaceuticals SL.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOVANTA TRIP ACTION GREEN APPLE AND HONEY- acetylsalicylic acid, menthol lozenge 
Applied Biological Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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biovanta Green Apple & Honey

Drug Facts

Drug Facts

Active Ingredient (in each lozenge):

Menthol 5mg......Antitussive

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

*nonsteroidal anti-inflammatory drug

Purpose

Antitussive and Analgesic

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.

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:

■ 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

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

■ 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

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

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

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

Directions

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

■ 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

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

biovanta Lemon & Honey

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

label

BIOVANTA TRIP ACTION GREEN APPLE AND HONEY 
acetylsalicylic acid, menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73678-260
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN6 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
HONEY (UNII: Y9H1V576FH)  
LACTOFERRIN, BOVINE (UNII: KG21X1090A)  
LYSOZYME (UNII: 968JKA7T33)  
ALOE (UNII: V5VD430YW9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
Product Characteristics
ColorgreenScoreno score
ShapeROUNDSize17mm
FlavorAPPLE (Honey) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73678-260-2424 in 1 BOX08/15/202009/01/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/202009/01/2022
Labeler - Applied Biological Laboratories Inc. (080512733)
Establishment
NameAddressID/FEIBusiness Operations
Lozy's Pharmaceuticals SL.466116516manufacture(73678-260)

Revised: 2/2022