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- NDC Code(s): 52083-600-16
- Packager: Kramer Novis
- Category: HUMAN OTC DRUG LABEL
- 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 November 13, 2019
If you are a consumer or patient please visit this version.
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- Active ingredients (in each 5 mL tsp)
Dextromethorphan HBr, USP 20 mg
See AlsoG-Zyncof Uses, Side Effects & WarningsDailyMed - G-ZYNCOF- dextromethorphan hbr and guaifenesin syrupNDC 52083-0400-04 ZYNCOF 20; 400 mg/5mL; mg/5mL Detailszyncof or g-zyncof: Side Effects, Uses, Interactions, Pictures, Warnings & DosingGuaifenesin, 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
- 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
G-ZYNCOF
dextromethorphan hbr and guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-600 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20mg in5mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400mg in5mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (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:52083-600-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/03/2012 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)
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G-ZYNCOF- dextromethorphan hbr and guaifenesin syrup
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Nov 15, 2019 | 2 (current) | download |
| Dec 3, 2012 | 1 | download |
RxNorm
G-ZYNCOF- dextromethorphan hbr and guaifenesin syrup
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 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
G-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.
| NDC | |
|---|---|
| 1 | 52083-600-16 |
