Label: SANATOS MUCUS RELIEF COLD TODDLERS- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 55758-307-02
- Packager: Pharmadel 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 January 13, 2022
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- Drug Facts
- Active Ingredients & Purposes
- Use
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Warnings
Do not use
in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- cough that is accompanied by excessive phlegm (mucus) or
- persistent or chronic cough such as occurs with asthma
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
SANATOS MUCUS RELIEF COLD TODDLERS
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 2.5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 2.5 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTITOL (UNII: D65DG142WK) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-307-02 59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 10/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/17/2017 Labeler - Pharmadel LLC (030129680)