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SUPRESS-PE Pediatric

Medically reviewed on January 29, 2018

Dosage form: solution/ drops
Ingredients: GUAIFENESIN 50mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Kramer Novis
NDC Code: 52083-056

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 Facts

Active Ingredients (in each 1 mL)                    Purpose

Guaifenesin, 50 mg..............................................Expectorant

Phenylephrine HCl, 2.5 mg................................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 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 your child has
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • a 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 to under 6 years of age 1 mL
children under 2 years of age
 ask physician


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.

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

Pricipal Display Panel

SUPRESS-PE

PEDIATRIC DROPS

EXPECTORANT

NASAL-DECONGESTANT

Great Grape Flavor

DYE FREE

ALCOHOL FREE

SACCHARINE FREE

NET CONTENT: 30 mL (1 Fl. Oz.)

MANUFACTURED IN USA FOR

KRAMER-NOVIS

San Juan, P.R. 00917

SUPRESS-PE  PEDIATRIC
guiafenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
PROPYLPARABEN 
SODIUM CITRATE 
SUCRALOSE 
SUCROSE 
Packaging
#Item CodePackage Description
1NDC:52083-056-0130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/14/2014
Labeler - Kramer Novis (090158395)

 
Kramer Novis

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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