ZYNCOF Tablets

Drug Labeling and Warnings

Drug Details [pdf]

ZYNCOF- dextromethorphan hydrobromide, guaifenesin tablet 
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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ZYNCOF Tablets

Drug Facts

Active Ingredients (in each immediate-release tablet)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Purpose

Cough Suppressant

Expectorant

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

Uses helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

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 accompanied by excessive phlegm (mucus) persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

When using this product do not exceed recommended dose do not use for more than 7 days

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

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

Directions Adults and children 12 years of age and older: take 1 tablet every 4 hours with a glass full of water while symptoms persist. Do not exceed 6 doses in 24 hours Children under 12 years of age: do not use

Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

Other information Tamper evident: Do not use if packet is torn, cut or opened Store at 25°C (77°F) excursions permitted between 15-30ºC (59-86°F) keep in a dry place and do not expose to excessive heat

Manufactured in the USA for Kramer Novis. San Juan, PR 00917.

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

Packaging

ZYNCOF 
dextromethorphan hydrobromide, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-410
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	TCL280
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-410-02	2 in 1 PACKET; Type 0: Not a Combination Product	06/26/2015	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/26/2015	05/31/2017

Labeler - KRAMER NOVIS (090158395)

Revised: 10/2019

Document Id: 8d087059-68b7-48c3-976f-f33d2429c73d

34390-5

Set id: 72f4ae9a-a31f-4cb8-8162-dafdb01912b1

Version: 3

Effective Time: 20191030

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