SUPRESS DX PEDIATRIC DROPS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Supress DX Pediatric Drops by

Drug Labeling and Warnings

Supress DX Pediatric Drops 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 1mL)

Dextromethorphan HBr, 5mg

Guaifenesin, 50mg

Phenylephrine HCl, 2.5mg

Purpose

Cough Suppressant

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 hay fever or other upper respiratory allergies (allergic rhinitis)
  • cough due to minor throat and bronchial irritation as may occur with 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 an 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 lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be 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.
• children 2 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, FD&C red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

SPL UNCLASSIFIED SECTION

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT

NO SUGAR ALCOHOL

Manufactured in the USA for Kramer-Novis

San Juan, PR 00917 Tel: (787) 767-2072

Packaging

INGREDIENTS AND APPEARANCE

SUPRESS DX PEDIATRIC DROPS 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-055
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	red (CHERRY RED)	Score
Shape		Size
Flavor	CHERRY (SOUR CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-055-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/29/2011

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)