Guaifenesin Syrup and Dextromethorphan
OTC - PURPOSE SECTION
Non-Narcotic - Alcohol Free
DRUG FACTS
Active Ingredient (in each 5 mL cup) PurposeGuaifenesin, USP 100mg .............................................................................................................................. ExpectorantDextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant
Active Ingredient (in each 10 mL cup) PurposeGuaifenesin, USP 200mg .............................................................................................................................. ExpectorantDextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant
Inactive Ingredients
Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.
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.
Warnings
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.
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
Ask a doctor or pharmacist before use if you are taking any other drug
Stop use and ask a doctor if
• your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.• you are hypersensitive to any of the ingredients
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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:
| Adults and children 12 years and over | 10 mL every 4 hoursMax dose is 60mL in 24-hours |
| Children under 12 years of age | Ask a doctor |
HOW SUPPLIED:
Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:
NDC 69339-149-05 (1) unit dose cup 5mLNDC 69339-149-19 100 (10x10) unit dose cups 5mL
Each 10 mL of Guaifenesin Syrup and Dextromethorphancontains Guaifenesin 200mg and DextromethorphanHydrobromide 20mg and is supplied in the following oraldosage forms:
NDC 69339-150-01 (1) unit dose cup 10mLNDC 69339-150-19 100 (10x10) unit dose cups 10mL
Other Information• Store at controlled room temperature 20-25ºC (68-77ºF)• Do not refrigerate• Keep tightly closed• Each 5mL contains sodium 3mg• Each 10mL contains sodium 6mg• Fruit punch flavor• Do not use if lid seal is open or damaged• See top of cup for lot number and expiration date
Questions or comments?Call 201-786-6500
Dash Pharmaceuticals LLCUpper Saddle River, NJ 07458
DP-UD-PI-AT-[117893] Rev 08/20