Gencontuss®

Gencontuss®
SPL v7
SPL
SPL Set ID 69d16d25-b09b-430e-8e01-0962d840dc21
Route
ORAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-08

Description

Chlorpheniramine Maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Chlorpheniramine Maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg

Uses

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

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

Temporarily restores freer breathing through the nose.

Section 42229-5

ANTIHISTAMINE

Chlorpheniramine Maleate

COUGH SUPPRESSANT

Dextromethorphan Hbr

NASAL DECONGESTANT

Phenylephrine Hcl

Cherry Flavor

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in the USA for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 50565-1

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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 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 • high blood pressure • thyroid disease • diabetes • glaucoma • difficulty in urination 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 before use if you are taking sedatives or tranquilizers

When using this product  do not exceed recommended dosage• drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • excitability occurs, especially in children • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 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 health professional before use.

Packaging

Directions

 • Do not exceed 6 doses in 24 hours.

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 2 to under 6 years of age  Ask a doctor.

Drug Facts

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.

Active Ingredients

Chlorpheniramine Maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl, 5 mg

Inactive Ingredients

citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.

Questions Or Comments?

call weekdays from 8 AM to 4 PM AST at 1.787.767.2072


Structured Label Content

Uses

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

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

Temporarily restores freer breathing through the nose.

Section 42229-5 (42229-5)

ANTIHISTAMINE

Chlorpheniramine Maleate

COUGH SUPPRESSANT

Dextromethorphan Hbr

NASAL DECONGESTANT

Phenylephrine Hcl

Cherry Flavor

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in the USA for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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 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 • high blood pressure • thyroid disease • diabetes • glaucoma • difficulty in urination 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 before use if you are taking sedatives or tranquilizers

When using this product  do not exceed recommended dosage• drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • excitability occurs, especially in children • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 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 health professional before use.

Packaging

Directions

 • Do not exceed 6 doses in 24 hours.

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 2 to under 6 years of age  Ask a doctor.

Drug Facts

Other Information (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.

Active Ingredients (Active ingredients)

Chlorpheniramine Maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl, 5 mg

Inactive Ingredients

citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.

Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 4 PM AST at 1.787.767.2072


Advanced Ingredient Data


Raw Label Data

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