Label: BIOVANTA TRIP ACTION LEMON AND HONEY- acetylsalicylic acid, menthol lozenge
- NDC Code(s): 73678-360-04, 73678-360-12, 73678-360-24
- Packager: Applied Biological Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
-
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 productAsk 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 diarrheaStop 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.
- Directions
- Other Information
- Inactive Ingredients
- biovanta Lemon & Honey
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOVANTA TRIP ACTION LEMON AND HONEY
acetylsalicylic acid, menthol lozengeProduct 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)
