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 |
Guaifenesin 200 mg ............................................................................ | Expectorant |
Dextromethorphan HBr 30 mg.................................................. | Cough suppressant |
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
Ask A Doctor Or Pharmacist Before 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.
- have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
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.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not exceed recommended dosage
- do not exceed 4 doses in a 24-hour period
- adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours
- children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours
- children under 6 years of age: do not use
Other Information
- store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
- store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
Inactive Ingredients
artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water
Questions?
+1-809-544-0222 (M-F) 9 AM to 5 PM Eastern or www.laboratoriosalfa.com
Principal Display Panel
Resfridol
Antitussive
Syrup
- Cough Suppressant
- Expectorant
Dextromethorphan Hbr and Guaifenesin
4 fl oz (120mL)
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