Otc - Active Ingredient
Active Ingredients (per 10ml = 2 teaspoonfuls)
Dextromethorphan HBr 20 mg
Guaifenesin, USP 200mg
Curewell Tussin Dm Liquid
FDA Label NDC 85111-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rmt Health Llc for the product Curewell Tussin Dm (NDC 85111-802). 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, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Cough Suppressant
Expectoran
Indications & Usage
Uses
• temporarily relieves cough due to minor throat and bronchial secretions to make coughs more productive
Warnings
Warnings
Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fir depression, psychiatric or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping drug contains an MAOI, as a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Otc - Stop Use
Stop use and ask a doctor if • cough lasts more that 7 days, comes back or is accompanied by fever, rash, or, persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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
Dosage & Administration
Directions
- do not exceed recommended dose
- take every 4 hours as needed, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 10mL (2 teaspoonfuls) |
| children under 12 years | Do not use |
Other Safety Information
Other information
• each 10 ml contains: sodium 20 mg
• TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing. •store at room temperature between
15°C-30°C (59°F-68°F) •protect from freezing •protect from light
Inactive Ingredient
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments? 1-845-367-0500 or [email protected]
* Please review the disclaimer below.
