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
Active Ingredient (in each lozenge):
Menthol 5mg......Antitussive
Acetyl Salicylic Acid* (NSAID)* 6 mg.......Analgesic
*nonsteroidal anti-inflammatory drug
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
| BIOVANTA TRIP ACTION GREEN APPLE AND HONEY
acetylsalicylic acid, menthol lozenge |
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| Labeler - Applied Biological Laboratories Inc. (080512733) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Lozy's Pharmaceuticals SL. | 466116516 | manufacture(73678-260) | |