NASOPEN  - chlorcyclizine hydrochloride and pseudoephedrine hydrochloride liquid 
GM Pharmaceuticals, Inc.

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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Drug Facts

Active Ingredients
(in each 5 mL teaspoonful)

Chlorcyclizine Hydrochloride 9.375 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine
Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.
Adults and children
12 years of age
and older:

2 teaspoonfuls (10 mL)
every 6 hours, not to
exceed 8 teaspoonfuls in a
24 hour period.
Children 6 to under
12 years of age:


1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period.
Children under 6
years of age:
consult a doctor


Other Information

Store at 59° to 86°F (15° to 30­°C).

Inactive Ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, and Sucralose.

Questions? Comments?

Call 1-888-535-0305

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 58809-578-01

NASOPEN

Each 5 mL (one Teaspoonful) contains:

Chlorcyclizine HCl...................9.375 mg
Pseudoephedrine HCl...................30 mg

Antihistamine / Nasal Decongestant

Cotton Candy Flavor

Alcohol Free / Gluten Free
Sugar Free / Dye Free

16 fl. oz. (473 mL)

GM Pharmaceuticals, Inc.


Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

This bottle is not to be dispensed to consumer.

Distributed by: GM Pharmaceuticals, Inc.
                          Arlington, Tx  76012

Patent Pending

Iss. 04/11


NASOPEN Packaging


NASOPEN Packaging





NASOPEN 
chlorcyclizine hydrochloride, pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-578
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride 9.375 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Sorbitol  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor COTTON CANDY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58809-578-01 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/06/2011

Labeler - GM Pharmaceuticals, Inc. (793000860)

Revised: 05/2011 GM Pharmaceuticals, Inc.