BIOVANTA TRIP ACTION LEMON AND HONEY- acetylsalicylic acid, menthol lozenge

Biovanta Trip Action Lemon and Honey by

Drug Labeling and Warnings

Biovanta Trip Action Lemon 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]

Drug Facts

Drug Facts

Active Ingredient

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:

■ has had stomach ulcers or bleeding problems
■ takes a blood thinning (anticoagulant) or steroid drug
■ takes other drugs containing prescription or nonprescription NSAlDs (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 per day while using this product

Ask a doctor before use

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: If pregnant or breast-feeding

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.

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 the 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

Dissolve1 lozenge slowly in mouth.
Repeat every 30 minutes 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 tamper seal is broken or missing.
■ Do not give lozenges to children younger than age 4.

■ Actual lozenge color may vary slightly due to the natural ingredients

Inactive Ingredients

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

biovanta Lemon & Honey

biovanta™

(NSAID*)

TRIPLE ACTION LOZENGES

• Fights Colds
• Soothes Sore Throats
• Relieves Coughs

Lemon & Honey

Non-Drowsy

24 Lozenges

NDC: 73678-360-24

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 TRIP ACTION LEMON AND HONEY 
acetylsalicylic acid, menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73678-360
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	6 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	ROUND	Size	17mm
Flavor	LEMON, HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73678-360-24	24 in 1 BOX	08/01/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 73678-360-04	4 in 1 BOX	02/01/2023
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 73678-360-12	12 in 1 BOX	02/01/2023
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2020

Labeler - Applied Biological Laboratories Inc. (080512733)

Establishment
Name	Address	ID/FEI	Business Operations
Lozy's Pharmaceuticals SL.		466116516	manufacture(73678-360)