Label: DOMETUSS-DMX- guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 53809-203-01, 53809-203-04, 53809-203-16
- Packager: Domel Laboratories
- 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 December 15, 2022
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- Drug FactsActive ingredients (in each 5 mL teaspoonful) contains
- Purpose
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
- Uses
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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
- If pregnant or breast-feeding
- Stop use and ask a doctor if
- Directions
- Inactive ingredients
- Other information
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- DOMETUSS-DMX product label
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INGREDIENTS AND APPEARANCE
DOMETUSS-DMX
guaifenesin, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53809-203 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53809-203-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2016 2 NDC:53809-203-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2016 3 NDC:53809-203-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/21/2016 Labeler - Domel Laboratories (808198837) Registrant - Domel Laboratories (808198837)