Otc - Active Ingredient
Dextromethorphan HBr, USP 15 mg
Dextromethorphan Hbr 15 Mg Capsule, Liquid Filled
FDA Label NDC 73629-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amz789 Llc for the product Dextromethorphan Hbr 15 Mg (NDC 73629-005). 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, use, warnings, otc - ask doctor/pharmacist, 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
Cough suppressant
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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.
Otc - Ask Doctor/Pharmacist
a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Otc - Stop Use
Stop use and ask a doctor if cough lasts for more than 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
do not take more than 8 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age
adults and children 12 years of age and over | take 2 capsules every 6 to 8 hours, as needed |
children under 12 years of age | do not use |
Other Safety Information
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light
Inactive Ingredient
FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Package Label.Principal Display Panel
Display Panel (Dp)
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