FDA Label for Family Care Cough And Cold
View Indications, Usage & Precautions
Family Care Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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 - Active Ingredient
Active ingredients (in each 10 mL) Purpose
Dextromethorphan HBr, USP 20 mg............................................Cough suppressant
Guaifenesin, USP 200 mg....................................................................Expectorant
Otc - Purpose
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.
Warnings
Warnings
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 until 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.
Otc - Ask Doctor
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Otc - Stop Use
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.
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.
Indications & Usage
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Keep dosing cup with product
- mL = milliliter
- this adult product is not intended for use in children under 12 years of age
| age | dose |
| adults and children 12 years and over | 10 mL every 4 hours |
| children under 12 years | do not use |
Storage And Handling
Other information
- each 10 mL contains: sodium 3 mg
- Store at 20° to 25°C (68° to 77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 USA
Made in Korea
Package Label.Principal Display Panel
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