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SUPRESS-PE

Kramer Novis

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in each 1 mL)                    Purpose

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

Phenylephrine HCl, 2.5 mg................................Nasal decongestant



Purpose

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

Uses


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

SUPRESS-PE

Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52083-056
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 50 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOLS
propylene glycol
water
PROPYLPARABEN
SODIUM CITRATE
Sucralose
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-056-01 30 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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