G-ZYNCOF - dextromethorphan hydrobromide and guaifenesin syrup 
Kramer Novis

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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G-ZYNCOF

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

When using this product do not use more than directed.

Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.

Made in the USA for Kramer Novis.

San Juan, PR 00917

(787) 767-2072 / www.kramernovis.com

PRINCIPAL DISPLAY PANEL

Q-Tussin DM 10mg/100mg

G-ZYNCOF 
dextromethorphan hbr and guaifenesin syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-600
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (GRAPE) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-600-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/03/2012
Labeler - Kramer Novis (090158395)

Revised: 12/2012
Document Id: f0ce44de-6405-4d1d-a431-31cc7492c890
Set id: c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc
Version: 1
Effective Time: 20121203
 
Kramer Novis