Guaifenesin Syrup And Dextromethorphan
97b137c9-0bec-409a-91f7-e298c296578b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Guaifenesin 100 mg .............................................................................................................................. Expectorant Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
Purpose
Guaifenesin 100 mg .............................................................................................................................. Expectorant Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
How Supplied
Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form: NDC 0904-7512-41: 5 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
Medication Information
Purpose
Guaifenesin 100 mg .............................................................................................................................. Expectorant Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
How Supplied
- Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
NDC 0904-7512-41: 5 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
Description
Guaifenesin 100 mg .............................................................................................................................. Expectorant Dextromethorphan hydrobromide 10 mg ............................................................................................ 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.
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 5 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 |
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.
Other Information
Each 5 mL contains: sodium 4 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
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)
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
Principal Display Panel 5 Ml Unit Dose Cup Label
Delivers 5 mL
NDC 0904-7512-41
GUAIFENESIN and
DEXTROMETHORPHAN
Syrup
100 mg/10 mg per 5 mL
See Insert for Drug Facts
For Institutional Use Only
Active Ingredient (in Each 5 Ml Cup) Purpose
Guaifenesin 100 mg .............................................................................................................................. Expectorant
Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
Structured Label Content
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.
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 5 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 |
Do Not Use (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.
How Supplied
- Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
NDC 0904-7512-41: 5 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
Other Information (Other information)
Each 5 mL contains: sodium 4 mg.
Store at 20° to 25°C (68° to 77°F). Protect from light.
Inactive Ingredients: (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? (Questions or comments?)
Call1-800-845-8210
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use
Keep Out of Reach of Children. (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)
Ask A Doctor Before Use If You Have (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
Principal Display Panel 5 Ml Unit Dose Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label)
Delivers 5 mL
NDC 0904-7512-41
GUAIFENESIN and
DEXTROMETHORPHAN
Syrup
100 mg/10 mg per 5 mL
See Insert for Drug Facts
For Institutional Use Only
Active Ingredient (in Each 5 Ml Cup) Purpose (Active ingredient (in each 5 mL cup) Purpose)
Guaifenesin 100 mg .............................................................................................................................. Expectorant
Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:30.388648 · Updated: 2026-03-14T23:07:26.290118