Label: SUPRESS DM- dextromethorphan hydrobromide, guaifenesin syrup
- NDC Code(s): 52083-058-01
- Packager: KRAMER NOVIS
- 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 November 23, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each 1 ml)
- Purpose
- Uses
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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 taking this product.
Ask a doctor before use if your child has
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma.
When using this product do not exceed the recommended dosage.
Stop use and ask a doctor if
- new symptoms occur
- coughs persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive ingredients
- Other information
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INGREDIENTS AND APPEARANCE
SUPRESS DM
dextromethorphan hydrobromide, guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 1 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY (SWEET CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-058-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/02/2013 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)
