DailyMed - ZYNCOF- dextromethorphan hbr and guaifenesin syrup (2024)

  • Label RSS
  • NDC Code(s): 52083-400-01, 52083-400-04, 52083-400-16
  • Packager: Kramer Novis
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 2, 2015

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  • Official Label (Printer Friendly)

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  • Active ingredients (in each 5 mL tsp)
  • Purpose

    Cough suppressant


  • 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
    • 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


    DailyMed - ZYNCOF- dextromethorphan hbr and guaifenesin syrup (2)

    dextromethorphan hbr and guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)
    Product Characteristics
    FlavorGRAPE (GRAPE) Imprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-400-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    2NDC:52083-400-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    3NDC:52083-400-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2011

    Labeler -Kramer Novis(090158395)

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ZYNCOF- dextromethorphan hbr and guaifenesin syrup

Number of versions: 3

Published Date (What is this?) Version Files
Jul 8, 2015 3 (current) download
Nov 6, 2012 2 download
Jun 20, 2011 1 download


ZYNCOF- dextromethorphan hbr and guaifenesin syrup

1 1113368 dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution PSN
2 1113368 dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution SCD
3 1113368 dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution SY
4 1113368 dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup SY

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NDC Codes

ZYNCOF- dextromethorphan hbr and guaifenesin syrup

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

1 52083-400-01
2 52083-400-04
3 52083-400-16
DailyMed - ZYNCOF- dextromethorphan hbr and guaifenesin syrup (2024)


What is Zyncof used for? ›

Zyncof is used to treat the symptoms of cough caused by the common cold, bronchitis and certain other respiratory diseases. To ensure the use and avoid side effects of Zyncof, patients should carefully read the instructions for use or follow the doctor's instructions for taking the drug.

How many days can you take dextromethorphan guaifenesin? ›

Guaifenesin and dextromethorphan should only be used for up to 7 days. Antihistamines can be taken long-term if you have allergies. But if you're only using them for a cold, check in with a healthcare provider if you're not feeling better after about 10 days. Oral decongestants should only be taken for up to 7 days.

What is dextromethorphan HBr guaifenesin used for? ›

DEXTROMETHORPHAN; GUAIFENESIN (dex troe meth OR fan; gwye FEN e sin) is a combination of a cough suppressant and expectorant. It is used for the temporary relief of coughs. This medicine is also used to loosen mucus.

How much cough syrup can you take a day? ›

Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed. Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

What are the side effects of G Zyncof? ›

Dizziness, drowsiness, nausea, and vomiting may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects.

What is the generic for Zyncof? ›

DEXTROMETHORPHAN; GUAIFENESIN (dex troe meth OR fan; gwye FEN e sin) is a combination of a cough suppressant and expectorant. It is used for the temporary relief of coughs. This medicine is also used to loosen mucus.

Can I take dextromethorphan every night? ›

More serious dextromethorphan side effects include serotonin syndrome. Dextromethorphan also carries the risk of misuse, which can potentially cause overdose. Don't take more than 120 mg per day of dextromethorphan. And don't take it for longer than 7 days.

Can too much guaifenesin be bad? ›

Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin. This medicine may make you dizzy or drowsy.

How much dextromethorphan to stop coughing? ›

The typical adult dose for cough is 15 to 30 mg taken three to four times daily. The cough- suppressing effects of DXM persist for 5 to 6 hours after ingestion. When taken as directed, side effects are rarely observed.

What does HBr stand for in cough syrup? ›

The hydrobromide salt form of dextromethorphan, a synthetic, methylated dextrorotary analogue of levorphanol, a substance related to codeine and a non-opioid derivate of morphine. Dextromethorphan exhibits antitussive activity and is devoid of analgesic or addictive property.

What is the maximum strength of guaifenesin and dextromethorphan HBr? ›

NDC 63824-072-35 - MAXIMUM STRENGTH - Mucinex®DM - 1200 mg guaifenesin & 60 mg dextromethorphan HBr - extended-release bi-layer tablets - EXPECTORANT & COUGH SUPPRESSANT - 12 - HOUR ...

What not to mix with dextromethorphan? ›

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, or tranylcypromine during treatment with this medication.

Why should you not take guaifenesin at night? ›

Should I take an expectorant during the day or at night? Guaifenesin and other expectorants work best during the daytime. An expectorant will cause you to cough more to clear congestion from the respiratory tract. While you can take it at night, it will not help you sleep and may keep you awake.

What happens if you take too much dextromethorphan? ›

Taking a lot of DXM causes hallucinations and out-of-body sensations similar to the ones caused by drugs like ketamine and PCP. These effects can last as long as 6 hours. DXM also can make users have trouble controlling their limbs and cause blurred vision, slurred speech, dizziness, and impaired judgment.

What are the ingredients in Zyncof? ›

G-ZYNCOF- dextromethorphan hbr and guaifenesin syrup.

What is the best mucus medicine for adults? ›

Guaifenesin is the most common expectorant medication available. It is commonly supplied as an oral tablet, capsule, solution, or syrup. Side effects of guaifenesin are generally mild, and most OTC cough medications that utilize it as an active ingredient are well tolerated by most older children and adults.

What is the best medicine for mucus in the chest? ›

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

What is the best medicine for chest congestion and cough? ›

Chest congestion medications, like Robitussin and Mucinex, come in liquid, tablet, and capsule forms. Both work for multiple symptoms although some people may prefer Robitussin for a cough and Mucinex for congestion. Robitussin and Mucinex are two over-the-counter remedies for chest congestion.

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