Otc - Active Ingredient
Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
Dextromethorphan Polistirex Extended-release Suspension
FDA Label NDC 65162-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals Llc for the product Dextromethorphan Polistirex Extended-release (NDC 65162-700). 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 and usage, warnings, otc - do not use, otc - ask doctor, 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
Purpose
Cough suppressant
Indications And Usage
Uses
Temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impulse to cough to help you get to sleep
Warnings
Warnings
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- chronic cough that lasts as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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 And Administration
Directions
- shake bottle well before use
- measure only with dosing cup provided. Do not use dosing cup with other products.
- dose as follows or as directed by a doctor
- each 5 mL contains: sodium 7 mg
- store at 20° to 25°C (68° to 77°F)
- dosing cup provided
- mL = milliliter
| adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
| children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
| children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
| Children under 4 years of age | do not use |
Other information
Inactive Ingredient
Inactive ingredients
citric acid, corn oil, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum
Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.
Otc - Questions
Questions?
Call 1-877-835-5472, Mon through Fri 9AM to 5PM EST.
Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807
Rev. 06-2016-00
* Please review the disclaimer below.
