NAUS-EASE - meclizine hydrochloride film, soluble 
Sunascen Therapeutics LLC

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.

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NAUS-EASE - Film; Product Information

Active Ingredients

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:

Chemical Structure


C25H27CIN2 - 2HCI - H2O    M.W. 481.89

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

  1. Do not exceed the recommended dosage
  2. May cause drowsiness
  3. Avoid alcoholic beverages while taking this product
  4. Alcohol, sedatives and tranquilizers may increase drowsiness
  5. Use caution when driving or operating machinery



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

Principal Display Panel

Meclizine HCl Film Strips, 25 mg Each
Antiemetic – Prevent and Treat: Nausea and Vomiting

 

Distributed by: Sunascen Therapeutics LLC
Rockville, MD 20850 USA

 
TAMPER EVIDENT: EACH FILM STRIP IS INDIVIDUALLY SEALED IN A POUCH. DO NOT USE IF INDIVIDUAL POUCH IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

Note:
Store at controlled room temperature 20-30°C. (68-86°F)
Protect from heat and humidity
Use by expiration date on package


NAUS-EASE 8 Film Strips: NDC 49467-104-01
NAUS-EASE 16 Film Strips: NDC 49467-104-16


Image of Carton Label

NAUS-EASE 
meclizine hydrochloride film, soluble
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49467-104
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTITOL (UNII: D65DG142WK)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
Product Characteristics
Color green Score no score
Shape RECTANGLE Size 22mm
Flavor LIME Imprint Code S1
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49467-104-01 8 in 1 CARTON
1 1 in 1 POUCH
2 NDC:49467-104-16 16 in 1 CARTON
2 1 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 04/16/2012
Labeler - Sunascen Therapeutics LLC (078272834)

Revised: 3/2013
Document Id: f766aeb1-5874-44b3-b47c-5ada3f082f58
Set id: 45ed34ea-457f-4d7e-8d2f-2c3ff5054a87
Version: 7
Effective Time: 20130303
 
Sunascen Therapeutics LLC