Label: COUGH MEDICINE SOOTHING RELIEF- dextromethorphan liquid
- NDC Code(s): 75663-002-01, 75663-002-10
- Packager: LM WHOLESALE HERBS
- 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.
Updated May 29, 2020
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- Active ingredient (in each 10 ml)
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
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Inactive Ingredients
- Other information
- Questions or comments?
- Package Label
INGREDIENTS AND APPEARANCE
COUGH MEDICINE SOOTHING RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75663-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 10 mL Inactive Ingredients Ingredient Name Strength APRICOT KERNEL OIL (UNII: 54JB35T06A) HONEY (UNII: Y9H1V576FH) FRITILLARIA DELAVAYI BULB (UNII: AG6Q756AT7) WATER (UNII: 059QF0KO0R) Product Characteristics Color brown (light brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75663-002-01 6 in 1 BOX 05/18/2020 1 NDC:75663-002-10 10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/18/2020 Labeler - LM WHOLESALE HERBS (104462911) Establishment Name Address ID/FEI Business Operations RFX Pharmaceutical Co., Ltd. 530620871 manufacture(75663-002)