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.
■ 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.
• 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.
Drug Facts
Menthol 5mg......Antitussive
Acetyl Salicylic Acid* (NSAID)* 6 mg.......Analgesic
*nonsteroidal anti-inflammatory drug
Antitussive and Analgesic
■ 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.
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:
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.
■ 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 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, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• 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.
■ 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.
Aloe, Honey, lsomalt, Lactoferin, Lysozyme, Natural Colors, Natural Apple Flavor, Stevia Rebaudiana, Sodium Chloride, Water
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
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73678-260-24 | 2022-02-01 | C162847 | 48780-1 | d6a99b39-4700-a426-e053-dadaa90af4c2 | biovanta Green Apple & Honey |
| 73678-260-24 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4700-a426-e053-dadaa90af4c2 | biovanta Green Apple & Honey |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73678-260 | 73678-260-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ISOMALT | S870P55O2W | IACT |
| HONEY | Y9H1V576FH | IACT |
| LACTOFERRIN, BOVINE | KG21X1090A | IACT |
| LYSOZYME | 968JKA7T33 | IACT |
| ALOE | V5VD430YW9 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| WATER | 059QF0KO0R | IACT |
| STEVIA REBAUDIANA WHOLE | 6U422Y08O2 | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d6faeafd-9bfc-48c1-e053-2a95a90a9796 | ae715d37-6178-2324-e053-2a95a90a166b | 2022-02-01 | Warnings | d6faeafd-9bfc-48c1-e053-2a95a90a9796 ae715d37-6178-2324-e053-2a95a90a166b |
Adverse event summaries are temporarily unavailable. Other product information remains available.