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NDC 52083-0650-16 GENCONTUSS 2; 10; 5 mg/5mL; mg/5mL; mg/5mL Details

GENCONTUSS 2; 10; 5 mg/5mL; mg/5mL; mg/5mL

GENCONTUSS is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 52083-0650-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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: 52083-0650-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 52083-0650-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	52083-0650
Product ID	52083-650_5d0747f8-3088-4716-896c-f71383c284c2
Associated GPIs	43995803120905
GCN Sequence Number	047004
GCN Sequence Number Description	chlorpheniramine/phenyleph/DM LIQUID 2-5-10MG/5 ORAL
HIC3	B3R
HIC3 Description	NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST
GCN	85914
HICL Sequence Number	000375
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN
Brand/Generic	Generic
Proprietary Name	GENCONTUSS
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	2; 10; 5
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	KRAMER NOVIS
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52083-0650-16 (52083065016)

Pricing Information	N/A
NDC Package Code	52083-650-16
Billing NDC	52083065016
Package	473 mL in 1 BOTTLE, PLASTIC (52083-650-16)
Marketing Start Date	2015-06-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 69d16d25-b09b-430e-8e01-0962d840dc21 Details

Drug Facts

Active Ingredients (in each 5mL tsp)

Chlorpheniramine Maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCL, 5 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

• For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy watery eyes due to hay fever or other upper respiratory allergies.

• Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold.

• Temporarily relieves nasal congestion and restores freer breathing through the nose.

Warnings

Do not use

• To sedate a child or to make a child sleepy.

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• Heart disease • Thyroid disease • Glaucoma • High blood pressure • Diabetes • Trouble urinating due to enlargement of the prostate gland • Cough that occurs with too much phlegm (mucus) • Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist: If you are taking sedatives or tranquilizers

When using this product

• DO NOT EXCEED RECOMMENDED DOSE.

• Marked drowsiness may occur • Excitability may occur, especially in children • Avoid alcoholic beverages • Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

• Nervousness, dizziness, or sleeplessness occur. • Symptoms do not improve within 7 days or are accompanied by fever• Cough persists for 1 week, tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a healthcare professional before use.

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 exceed 6 doses in a 24-hour period, unless directed by a doctor


Adults and children 12 years of age and older	2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age	Do not use

Other information

• Tamper evident feature: Do not use if inner seal is torn, broken or missing.

• Store at controlled room temperature 15-30⁰C(59-86⁰F).

• Avoid excessive heat or humidity.

Inactive Ingredients

Purified water, potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sucralose, cherry flavor, and FD&C red#40.

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Rycontuss®*

ANTIHISTAMINE

COUGH SUPPRESSANT

NASAL DECONGESTANT

Cherry Flavor

Manufactured in the USA for Kramer Novis, San Juan, PR 00917. Tel:(787) 767-2072 www.kramernovis.com

*Rycontuss® is a registered trademark of Okendpharma Inc. This product is not manufactured, distributed or marketed by Okendpharma Inc.

Packaging

INGREDIENTS AND APPEARANCE

GENCONTUSS

chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52083-650
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red (Clear Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52083-650-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/08/2015

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)

Revised: 10/2022

Document Id: 5d0747f8-3088-4716-896c-f71383c284c2

Set id: 69d16d25-b09b-430e-8e01-0962d840dc21

Version: 5

Effective Time: 20221015