Label: SOOTHE COMFORT II COUGH SYRUP HERBAL MINT- dextromethorphan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76206-005-01, 76206-005-05 - Packager: RFX Pharmaceutical Co., Ltd.
- 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 April 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 ml/2TBSP)
- Purpose
- Use
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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.
- 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
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Directions
■ do not take more than 4 doses in any 24-hour period
■ one dose is two tablespoons (TBSP)
■ this adult product is not intended for use in children under 12 years of age
Age Dose
adults and children 12 years 30 mL (2TBSP)
and over every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
- Other Information
- Inactive ingredients
- Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
SOOTHE COMFORT II COUGH SYRUP HERBAL MINT
dextromethorphan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76206-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL Inactive Ingredients Ingredient Name Strength MORUS ALBA ROOT BARK (UNII: SV6B76DK9N) TUSSILAGO FARFARA FLOWER BUD (UNII: 6WBB6U5V2Q) HONEY (UNII: Y9H1V576FH) FRITILLARIA PRZEWALSKII BULB (UNII: 8B269H8XVH) SCHISANDRA CHINENSIS FRUIT OIL (UNII: 62023A4393) SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW) WATER (UNII: 059QF0KO0R) PEPPERMINT OIL (UNII: AV092KU4JH) 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:76206-005-01 1 in 1 BOX 04/23/2021 1 NDC:76206-005-05 155 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 04/23/2021 Labeler - RFX Pharmaceutical Co., Ltd. (530620871)
