G-ZYNCOF: Package Insert and Label Information

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.

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
(click image for full-size original)

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 (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EUCALYPTUS OIL
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
POLYETHYLENE GLYCOL 1450
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE (GRAPE) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52083-600-16 473 mL in 1 BOTTLE, PLASTIC None
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)
Registrant — Kramer Novis (090158395)

Revised: 11/2019 Kramer Novis

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