Green Tussin Dm Pediatric
FDA Label NDC 55287-443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Green Choice For Life for the product Green Tussin Dm Pediatric (NDC 55287-443). 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 15 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 15 Ml)
Dextromethorphan HBr 10 mg
Guaifenesin 100 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 exceed recommended dosage.
Do not use:
• Ask a doctor before use for a persistent or chronic cough such as occurs with asthma, chronic bronchitis or if cough is accompanied by excessive phlegm (mucus).
• Stop use and ask a doctor if cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOl) (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 child's prescription drug contains an MAOl, ask a doctor or pharmacist before giving this product.
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.
Directions
• Do not exceed 6 doses in 24 hours.
| age | dose |
| children 6 to under 12 years of age | 15 mL (3 TSP) every 4 hours |
| children 2 to under 6 years of age | 7.5 mL (1 ½TSP) every 4 hours |
Other Information
• store this product between 15 to 30°C (59° to 86°F)
Inactive Ingredients:
Aloe, Citric Acid, Caramel Color, Corn Syrup, Eucalyptus Oil, Ginger Root PE, Honey, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.
Questions?
call 305-763-3228 M-F 9 am to 5 pm Eastern.
Packaging
Pediatric (5528744306 3)
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