Label: MUCINEX INSTASOOTHE COUGH- dextromethorphan hydrobromide lozenge
- NDC Code(s): 72854-267-20, 72854-267-40
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 23, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- Uses
- PURPOSE
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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.
■ in children under 6 years of ageAsk a doctor before use if:
■ persistent or chronic cough such 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, comes back, or occurs with fever,
- rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breastfeeding:- ask a health professional before use.
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Other Infomation
- Inactives
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCINEX INSTASOOTHE COUGH
dextromethorphan hydrobromide lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-267 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 Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) ISOMALT (UNII: S870P55O2W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) Product Characteristics Color purple Score no score Shape ROUND Size 18mm Flavor BERRY Imprint Code S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-267-20 20 in 1 BAG 04/01/2024 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:72854-267-40 40 in 1 BAG 04/01/2024 2 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/01/2024 Labeler - RB Health (US) LLC (081049410)
