Elp Essential Dm
FDA Label NDC 70242-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Elp Essential Dm (NDC 70242-139). 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 5 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 5 Ml)
Dextromethorphan HBr USP 10mg
Guaifenesin USP 100mg
Purpose
Cough Suppressant
Expectorant
Uses
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Warnings
Do not exceed recommended dosage.
Do not use
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric 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 your doctor or pharmacist before taking this product.
• If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
• Avoid alcoholic beverages while you taking this product.
Ask the doctor before use if you have
• Cough that occurs with too much phlegm (mucus)
• Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Stop use and ask the doctor if
• Nervousness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign serious condition
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.
Directions:
• Do not take more than 6 doses in any 24-hour period.
• Shake well before use.
| Age | Dose |
| Adults and Children 12 years and over | 10ml (2 tsps) every 4 hours |
| Children 6 to under 12 years of age. | 5ml (1 tsps) every 4 hours |
| Children under 6 years of age | Do not use |
Other Information
• Each 5 ml contains: sodium 8 mg
• Store Between 15-30° C (59-86° F)
• Tamper Evident Feature Do not use if seal under cap is torn, broken or missing
Inactive Ingredients
Blue Cohosh, Citric Acid, Echinacea, Eucalyptus Oil, Ginkgo Biloba, Golden Seal Root, Honey Pure, Honey flavor, Horehound Herb, Licorice Root, Menthol, Mullein, Myrrh, Potassium Sorbate, Slippery Elm Bark, Sodium Benzoate, Propylene Glycol, Purified Water, Sodium Chloride, Sucralose, Wild Cherry bark and Zinc Sulfate.
Questions Or Comments?
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Packaging
Elp Essential Dm-139 (7024213906)
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