Dr. Sana Cough And Chest Congestion Dm Sugar Free Syrup
FDA Label NDC 53113-515
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories, Inc for the product Dr. Sana Cough And Chest Congestion Dm Sugar Free (NDC 53113-515). 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 drug facts, active ingredients: (in each 30 ml), purpose, uses, warnings, otc - keep out of reach of children, directions:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients: (In Each 30 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin USP 200 mg
Purpose
Cough Suppressant
Expectorant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
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 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.
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.
Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask 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.
Directions:
• do not exceed more than 6 doses in any 24-hour period
• shake well before use
• mL=milliliter
| age | dose |
| adults and children 12 years & more | 2 tablespoons (30 mL) every 4 hours |
| children under 12 years of age | consult your doctor |
Other Information
• Each 30 ml contains: Sodium 4.8 mg
• Store Between 15°C to 30°C (59°F to 86°F)
• Tamper Evident Feature: Do not use if seal under cap is torn, broken or missing.
Inactive Ingredients
Aloe Vera, Citric Acid, Caramel Color, Eucalyptus Oil, Ginger Root PE, Glycerin, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.
Questions?
call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900
Packaging
Cough&chest Congestion (531130515 3)
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