Otc - Active Ingredient
Dextromethorphan HBr 20mg
Guaifenesin 400mg
Cough Mucus Relief Dm
FDA Label NDC 70692-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Cough Mucus Relief Dm (NDC 70692-101). 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 otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid
* May contain hydroxypropyl methylcellulose, polyethylene glycol
Dosage & Administration
* take with a full glass of water
* swallow whole; do not crush, chew or dissolve
*do not take more than 6 tablets in 24 hours
| adults and children 12 years of age and over | 1 tablet every 4 hours |
| children under 12 years of age | Do not use |
Indications & Usage
* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
* 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
* persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis,or emphysema
* cough accompanied by too much phlegm (mucus)
When using this product do not use more than directed
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with 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.
Otc - 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.
Otc - Purpose
Cough Suppressant
Expectorant
Other Safety Information
* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)
* Please review the disclaimer below.
