FDA Label for Biovanta Trip Action Lemon And Honey
View Indications, Usage & Precautions
Biovanta Trip Action Lemon And Honey Product Label
The following document was submitted to the FDA by the labeler of this product Applied Biological Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 Lemon Flavor, Stevia Rebaudiana, Sodium Chloride, Water
Biovanta Lemon & Honey
bio vanta™
(NSAID*)
TRIPLE ACTION
SOOTHES SORE THROATS.
FIGHTS COLDS & COUGH.
Natural Bioactive Ingredients
Lemon & Honey
24 Lozenges
NDC 73678-360-24
Distributed by:
Applied Biological Laboratories
760 Parkside Ave.
317, 327-D and 327-F
Brooklyn, New York 11226
* Please review the disclaimer below.