Guaifenesin Syrup And Dextromethorphan Syrup
FDA Label NDC 69339-149

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natco Pharma Usa Llc for the product Guaifenesin Syrup And Dextromethorphan (NDC 69339-149). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, drug facts, inactive ingredients, uses, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Non-Narcotic - Alcohol Free

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.

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.

Otc - 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.

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

If pregnant or breast-feeding, ask a health professional before use

Otc - 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)

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

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

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