NAUS-EASE

Sunascen Therapeutics LLC

NAUS-EASE - Film; Product Information

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients
• Purpose
• Keep out of reach of children
• Indications and Use
• Warnings
• Directions
• Inactive Ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active Ingredients

Purpose

Keep out of reach of children

Indications and Use

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: Oral dosage is 1 to 2 film strips (25 to 50mg) once daily, or as directed by a physician. Place 1 to 2 film strips on the tongue to completely dissolve then swallow.

Inactive Ingredients

• polyethylene oxide
• hydroxypropyl methylcellulose
• maltitol
• acesulfame potassium
• citric acid
• sodium citrate

Principal Display Panel

NAUS-EASE MECLIZINE HYDROCHLORIDE FILM, SOLUBLE Product Information Product Type Human otc drug label Item Code (Source) NDC:49467-104 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 POLYETHYLENE GLYCOLS HYPROMELLOSES MALTITOL ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ANHYDROUS TRISODIUM CITRATE Product Characteristics Color Size Imprint Code Shape green 22 mm S1 RECTANGLE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 2 1 in 1 POUCH 3 NDC:49467-104-16 16 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part336 2012-04-16