Supress-pepediatric solution/ drops

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 Parkinsons 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.

Otc - keep out of reach of children section

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 age Consult 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 15-30C (59-86F).
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.

Spl unclassified section

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

Ingredients and appearance - Product information

Supress-pepediatric solution/ drops- Guiafenesin, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52083-056
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 50 mgin 1 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Kramer Novis( 090158395)

Packaging