ZYNCOF- dextromethorphan hbr and guaifenesin syrup

ZYNCOF by

Drug Labeling and Warnings

ZYNCOF by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PREGNANCY OR BREAST FEEDING

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.

SPL UNCLASSIFIED SECTION

Made in the USA for Kramer Novis.

San Juan, PR 00917

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZYNCOF 
dextromethorphan hbr and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-400
Route of Administration	ORAL

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: 52083-400-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2011
2	NDC: 52083-400-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2011
3	NDC: 52083-400-16	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2011

Labeler - Kramer Novis (090158395)