Guaifenesin Syrup and Dextromethorphan GUAIFENESIN AND DEXTROMETHORPHAN NATCO PHARMA USA LLC FDA Approved 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.

Drug Facts

Composition & Profile

Active Ingredients
DRUG FACTS Active Ingredient (in each 5 mL cup) Purpose Guaifenesin USP 100mg .............................................................................................................................. Expectorant Dextromethorphan HBr USP 10mg ...................................................................................................... Cough Suppressant Active Ingredient (in each 10 mL cup) Purpose Guaifenesin USP 200mg .............................................................................................................................. Expectorant Dextromethorphan 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.
Inactive Ingredients
Inactive Ingredients Anhydrous citric acid dextrose FD&C Red No. 40 flavor glycerin high fructose corn syrup menthol purified water saccharin sodium sodium benzoate.
Strengths
5 ml 100 mg 10 mg 10 ml 200 mg 20 mg
Quantities
5 ml 10 ml
Treats Conditions
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
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
UNII
495W7451VQ 9D2RTI9KYH
Packaging

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 5mL NDC 69339-149-19 100 (10x10) unit dose cups 5mL Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 69339-150-01 (1) unit dose cup 10mL NDC 69339-150-19 100 (10x10) unit dose cups 10mL; PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 69339-149-05 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 100 mg/10 mg per 5 mL For Institutional Use Only 3 69339 14905 8 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 5mL Cup Label; PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 69339-150-01 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 200 mg/20 mg per 10 mL For Institutional Use Only 3 69339 15001 6 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 10 mL cup label

Package Descriptions
  • 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 5mL NDC 69339-149-19 100 (10x10) unit dose cups 5mL Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 69339-150-01 (1) unit dose cup 10mL NDC 69339-150-19 100 (10x10) unit dose cups 10mL
  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 69339-149-05 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 100 mg/10 mg per 5 mL For Institutional Use Only 3 69339 14905 8 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 5mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 69339-150-01 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 200 mg/20 mg per 10 mL For Institutional Use Only 3 69339 15001 6 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 10 mL cup label

Overview

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.

Indications & Usage

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.

Dosage & Administration

DIRECTIONS: Age Dose Adults and children 12 years and over 10 mL every 4 hours Max dose is 60mL in 24-hours Children under 12 years of age Ask a doctor

Warnings & Precautions
Warnings 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 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)
Purpose

Non-Narcotic - Alcohol Free

Do Not Use

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.

Stop Use & Ask a Doctor

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

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)

Storage & Handling

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


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