Adult Cough Suppressant Dextromethorphan Hbr Capsule, Liquid Filled
FDA Label NDC 0536-1480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Adult Cough Suppressant Dextromethorphan Hbr (NDC 0536-1480). 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 ingredient (in each softgel), purpose, use, 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 Ingredient (In Each Softgel)
Dextromethorphan HBr, USP 15 mg
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 MAΟΙ drug. If you do not know if your prescription drug contains an MAΟΙ, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• a cough that occurs with too much phlegm (mucus)
• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
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.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• do not take more than 8 softgels 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 and older | take 2 softgels every 6 to 8 hours, as needed |
| children under 12 years | do not use |
Other Information
• store below 25°C (77°F)
• avoid excessive heat above 40°C(104°F)
• protect from light
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propyl gallate, propylene glycol, purified water, Polyvinylpyrrolidone, sorbitol sorbitan solution
Questions Or Comments?
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Packaging
Cough Suppressant (05361480 1)
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