NAUZENE GRAPE- lactic acid, wild hops liquid

Nauzene Grape by

Drug Labeling and Warnings

Nauzene Grape by is a Homeopathic medication manufactured, distributed, or labeled by Denison Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15-mL tablespoon)

Lactic acid 3x (20 mg)(Lacticum acidum)

Wild hops 3x (20 mg)(Bryonia alba)

Purpose

Nausea reliever

Uses

For the relief of upset stomach and nausea, including that due to "stomach flu", "car sickness" or overindulgence in food or drink.

Warnings

DO NOT USE

Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

ASK DOCTOR

Ask a doctor before use if you

• have diabetes because this product contains sugar

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other medications.

WHEN USING

When using this product do not take more than 6 tablespoons in a 24-hour period.

STOP USE

Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• Read all package directions and warnings before use and use only as directed.

• Children under 2 yrs: Ask a doctor
• Children 2 yrs and up Adults:

  1 - 2 tablespoons

  (15 - 30 mL)

• Use only with enclosed dosing cup.
• Dosage may be repeated after 30 minutes not to exceed 6 tablespoons in a 24-hour period unless advised by a doctor.
• For maximum effectiveness never dilute Nauzene Kids or drink fluids of any kind immediately before or after taking Nauzene Kids.
• Nauzene Kids is intended for use by normally healthy persons only.

Other information

• Sodium content: 5 mg/tablespoon (15-mL)
• Potassium content: 10 mg/tablespoon (15-mL)
• Store at room temperature.
• **Contents sealed: Each bottle of Nauzene Kids has a tamper evident seal around the cap and a safety seal under the cap. Do not use if either of these seals appears broken.
• You may report serious side effectes to the phone number provided under Questions? below.

Inactive ingredients

Corn syrup (contains glucose), fructose syrup, glycerin, natural grape flavor, phosphoric acid, potassium sorbate, purified water.

QUESTIONS

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAUZENE GRAPE 
lactic acid, wild hops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-7208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 15 mL
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	3 [hp_X]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
GLYCERIN (UNII: PDC6A3C0OX)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-7208-17	1 in 1 CARTON	01/18/2019
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2019

Labeler - Denison Pharmaceuticals Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals Inc.		001207208	manufacture(0295-7208)