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NDC 52083-0055-01 Supress DX Pediatric Drops 5; 50; 2.5 mg/mL; mg/mL; mg/mL Details

Supress DX Pediatric Drops 5; 50; 2.5 mg/mL; mg/mL; mg/mL

Supress DX Pediatric Drops is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 52083-0055-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 52083-0055-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 52083-0055-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	52083-0055
Product ID	52083-055_e9d05532-a0d0-48e8-bd95-c6275bfbe8a5
Associated GPIs	43997303100940
GCN Sequence Number	040290
GCN Sequence Number Description	guaifen/dextromethorphan/PE DROPS 50-5-2.5/1 ORAL
HIC3	B4R
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
GCN	53092
HICL Sequence Number	000216
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Brand/Generic	Brand
Proprietary Name	Supress DX Pediatric Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	5; 50; 2.5
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	KRAMER NOVIS
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52083-0055-01 (52083005501)

Pricing Information	N/A
NDC Package Code	52083-055-01
Billing NDC	52083005501
Package	30 mL in 1 BOTTLE (52083-055-01)
Marketing Start Date	2011-03-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ddb95436-7806-4086-af4d-18a6625b5c83 Details

Drug Facts

Active Ingredients (in each 1 mL)

Dextromethorphan HBr, 5mg

Guaifenesin, 50mg

Phenylephrine HCl, 2.5mg

Purposes

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

• 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. • Store at controlled room temperature 15-30°C (59-86°F)

Inactive Ingredients

• Citric acid, FD&C Red 40, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water and Sucralose.

Questions or comments?

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

SPL UNCLASSIFIED SECTION

Sugar & Alcohol Free

Kramer Novis Pharmaceuticals within reach of patients

Manufactured in the USA for Kramer Novis, San Juan, PR 00917. www.kramernovis.com

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

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

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

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)

Revised: 5/2022

Document Id: e9d05532-a0d0-48e8-bd95-c6275bfbe8a5

Set id: ddb95436-7806-4086-af4d-18a6625b5c83

Version: 4

Effective Time: 20220512