Label: SUPRESS-PE PEDIATRIC- guiafenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 52083-056-01
- 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 22, 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 a MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure • diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthmaWHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE
Stop use and ask a doctor if
• your child gets nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition. - Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
SUPRESS-PE PEDIATRIC
guiafenesin, phenylephrine hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-056 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 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) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-056-01 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/14/2014 Labeler - Kramer Novis (090158395)
