FDA Label for Guaifenesin Syrup And Dextromethorphan
View Indications, Usage & Precautions
- 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
- OTC - KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 5 ML UNIT DOSE CUP LABEL
- PRINCIPAL DISPLAY PANEL - 10 ML UNIT DOSE CUP LABEL
Guaifenesin Syrup And Dextromethorphan Product Label
The following document was submitted to the FDA by the labeler of this product Natco Pharma Usa Llc. 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.
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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