Nauzene Grape

Manufacturer
Denison Pharmaceuticals Inc.
Effective date
2019-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:33:28

Label at a glance#

ProductNauzene Grape
Active ingredientBRYONIA ALBA ROOT, LACTIC ACID
Label structure15 sections

Indications and uses

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

Dosage and administration

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 be...

Label contents#

Full prescribing information#

Active ingredients (in each 15-mL tablespoon)

OTC - ACTIVE INGREDIENT SECTION

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

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

Purpose

OTC - PURPOSE SECTION

Nausea reliever

Uses

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

  • have diabetes because this product contains sugar

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Read all package directions and warnings before use and use only as directed.
Children under 2 yrsAsk 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

INFORMATION FOR PATIENTS SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-72080295-7208-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7fbe1664-edc8-b7db-e053-2991aa0af7e67fbe1664-edc7-b7db-e053-2991aa0af7e62019-01-18WarningsExact identifier
spl id: 7fbe1664-edc8-b7db-e053-2991aa0af7e6
spl set id: 7fbe1664-edc7-b7db-e053-2991aa0af7e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.