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NAUS-EASE

Sunascen Therapeutics LLC

NAUS-EASE (Meclizine HCl) Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Meclizine HCl  25 mg

Meclizine Hydrochloride is an oral antiemetic. It is a white to slightly yellow crystalline powder which has a slight odor and is tasteless. Meclizine HCl has the following structural formula:

NAUS-EASE

C25H27CIN2 - 2HCI - H2O    M.W. 481.88 g/mol

The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate. 

Purpose

Antiemetic

Keep out of reach of children

Keep out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222.

Indications and Use

For the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness

Warnings

  • Not for use in children under 12 years of age unless directed by a doctor.
  • Do not take unless directed by a doctor if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland.
  • Ask a doctor before use if you are taking sedatives or tranquilizers.
  • When using this product:
  • Do not exceed the recommended dosage
  • May cause drowsiness
  • Avoid alcoholic beverages while taking this product
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Use caution when driving or operating machinery


  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222

Directions

Adults and children 12 years of age and over: Take 1 to 2 tablets (25 mg to 50 mg) by mouth once daily, or as directed by a doctor.

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, D&C Yellow No. 10 Aluminum Lake

Principal Display Panel

Meclizine HCl Tablets, 25 mg
Antiemetic – Prevent and Treat: Nausea and Vomiting


Distributed by: Sunascen Therapeutics LLC
Rockville, MD 20850 USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Note:
Store at controlled room temperature 20-25°C (68-77°F)
Protect from heat and humidity
Use by expiration date on package

NAUS-EASE 8 tablets - NDC 49467-124-08
NAUS-EASE 16 tablets - NDC 49467-124-16

NAUS-EASE

NAUS-EASE

MECLIZINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49467-124
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE MECLIZINE 25 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
lactose monohydrate
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
cellulose, microcrystalline
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
yellow 13 mm TL121 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 NDC:49467-124-16 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040659 2012-04-16


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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