Your browser does not support JavaScript! G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]
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G-ZYNCOF (dextromethorphan hbr and guaifenesin) syrup
[Kramer Novis]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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

  • do not take more than 6 doses in any 24-hour period
  • EVERY 4 HOURS
  • Adults and Children 12 years of age and over 5 mL (1 tsp)
  • Children under 12 years of age consult physician

Other information

  • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat or humidity.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52083-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
MENTHOL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 1450 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-600-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/2012
Labeler - Kramer Novis (090158395)

Revised: 12/2012
 
Kramer Novis

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