FDA Label for Guaifenesin And Dextromethorphan
View Indications, Usage & Precautions
- ACTVE INGREDIENT (IN EACH 10 ML) PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS:
- QUESTIONS OR COMMENTS?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL -10 ML UNIT DOSE CUP
Guaifenesin And Dextromethorphan Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Actve Ingredient (In Each 10 Ml) Purpose
Guaifenesin 200mg ...................................................................................................................................... Expectorant
Dextromethorphan hydrobromide 20mg .......................................................................................................Cough Suppressant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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
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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
Follow dosage below or use as directed by a physician.
do not take more than 6 doses in any 24-hour period.
single use cup. Dose only with cup provided.
each cup delivers 10 mL
mL = Milliliter
| Age (yr) | Dose (mL) |
|---|---|
| adults and children 12 years and over | 10 mL every 4 hours |
| children 6 years to under 12 years | 5 mL every 4 hours |
| children under 6 years of age | ask a doctor |
Other Information
Each 10 mL contains: sodium 8 mg.
Store at 20° to 25°C (68° to 77°F). Protect from light.
Inactive Ingredients:
anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, menthol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sucrose.
Questions Or Comments?
Call1-800-845-8210
How Supplied
- Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
NDC 0904-7513-66: 10 mL unit dose cup, in a tray of ten cups
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
R10/24
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel -10 Ml Unit Dose Cup
Delivers 10 mL
NDC 0904-7513-66
GUAIFENESIN DEXTROMETHORPHAN
200 mg/20 mg per 10 mL
See Insert for Drug Facts
For Institutional Use Only
* Please review the disclaimer below.
