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

SUPRESS-PE by

Drug Labeling and Warnings

SUPRESS-PE by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 15-30°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.

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

Packaging

INGREDIENTS AND APPEARANCE

SUPRESS-PE  PEDIATRIC
guiafenesin, phenylephrine hcl solution/ drops

Product 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)