Label: DELSYM COUGH RELIEF PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 63824-161-16 - Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 14, 2012
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Sore throat warning
- If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.
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, or emphysema
- cough that is accompanied by excessive phlegm (mucus)
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Directions
- adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
- children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
- children under 6 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack
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INGREDIENTS AND APPEARANCE
DELSYM COUGH RELIEF PLUS SOOTHING ACTION
dextromethorphan hydrobromide and menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg Inactive Ingredients Ingredient Name Strength D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C red no. 40 (UNII: WZB9127XOA) isomalt (UNII: S870P55O2W) propylene glycol (UNII: 6DC9Q167V3) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) water (UNII: 059QF0KO0R) Product Characteristics Color RED Score no score Shape ROUND Size 27mm Flavor CHERRY Imprint Code D Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-161-16 16 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/2012 Labeler - Reckitt Benckiser LLC (094405024)