FDA Label for Resfridol Antitussive
View Indications, Usage & Precautions
Resfridol Antitussive Product Label
The following document was submitted to the FDA by the labeler of this product Laboratorios Alfa. 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
| Active ingredients (in each 10 mL) | Purposes |
| Dextromethorphan HBr 5 mg ............................................................................ | Cough suppressant |
| Guaifenesin 200 mg........................................................................................... | Expectorant |
Uses
Temporarily relieves common cold symptoms:
- cough due to minor throat & bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to:
- drain bronchial tubes
- make coughs more productive
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 for 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.
Stop Use And Ask A Doctor If
■ a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
■a cough that is accompanied by excessive phlegm (mucus)
■ a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
■ only use the dosage cup provided
■ shake well before use
■ do not exceed 6 doses per 24-hour period
| Age | Dose |
| adults and children 12 years and older | 20 mL, every 4 hours |
| children 6 to under 12 years | 10 mL, every 4 hours |
| children under 6 years | do not use |
Other Information
■ store between 68-77°F (20-25°C)
■ do not use if safety seal over cap is torn, broken, or missing
Inactive Ingredients
anhydrous citric acid, FD&C red #40, flavors, sodium benzoate, sorbitol, sucralose, water
Questions?
+1-809-544-0222
(M-F) 9 AM - 5 PM EST or www.laboratoriosalfa.com
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