SUPRESS-PE PEDIATRIC- guiafenesin, phenylephrine hcl solution/ drops 
Kramer Novis

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.

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SUPRESS-PE Pediatric

Drug Facts

Active Ingredients (in each 1 mL)

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg

Purpose

Expectorant

Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves nasal congestion due to the common cold

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 asthma

WHEN 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.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not use more than 6 doses in any 24-hour period
• repeat every 4 hours
• measure with the dosage device provided. Do not use with any other device

 age dose
 children 2 years to under 6 years of age 1 mL
 children under 2 years of ageConsult a doctor

Other information

• Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat and humidity.

Inactive ingredients

Citric acid, glycerin, grape flavor, methylparaben, polyethylene glycol, purified water, propylene glycol, propylparaben, sodium citrate, sucralose and sucrose.

SUPRESS-PE

PEDIATRIC DROPS

EXPECTORANT

NASAL-DECONGESTANT

Great Grape Flavor

DYE FREE

ALCOHOL FREE

SACCHARINE FREE

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072 www.kramernovis.com

Packaging

image description

SUPRESS-PE  PEDIATRIC
guiafenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-056-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/14/2014
Labeler - Kramer Novis (090158395)

Revised: 11/2018
Document Id: 6b4b229d-56e9-4920-9549-f60f50667f27
Set id: a474171d-5c29-4a80-9d37-00613796211a
Version: 3
Effective Time: 20181122
 
Kramer Novis