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.

----------

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

zlbl

ZYNCOF 
dextromethorphan hydrobromide, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52083-410
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code TCL280
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52083-410-022 in 1 PACKET; Type 0: Not a Combination Product06/26/201505/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/26/201505/31/2017
Labeler - KRAMER NOVIS (090158395)

Revised: 10/2019
 <

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.