Supress®

Supress®
SPL v4
SPL
SPL Set ID a474171d-5c29-4a80-9d37-00613796211a
Route
ORAL
Published
Effective Date 2025-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-14

Description

Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg

Purpose

Expectorant Nasal decongestant


Medication Information

Purpose

Expectorant Nasal decongestant

Description

Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg

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

Section 42229-5

PEDIATRIC DROPS

For Relief of:

+ Chest Congestion/Mucus

+ Stuffy Nose

+ Sinus Congestion

Sugar, Dye & Alcohol Free

Grape Flavor

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

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

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Expectorant

Nasal decongestant

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 a 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.

Packaging

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.

Drug Facts

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).

• Avoid excessive heat and humidity.

Inactive Ingredients

Citric acid, glycerin, grape flavor, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

Questions Or Comments?

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml)

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Structured Label Content

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

Section 42229-5 (42229-5)

PEDIATRIC DROPS

For Relief of:

+ Chest Congestion/Mucus

+ Stuffy Nose

+ Sinus Congestion

Sugar, Dye & Alcohol Free

Grape Flavor

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Expectorant

Nasal decongestant

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 a 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.

Packaging

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.

Drug Facts

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).

• Avoid excessive heat and humidity.

Inactive Ingredients (Inactive ingredients)

Citric acid, glycerin, grape flavor, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

Questions Or Comments? (Questions or comments?)

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml) (Active ingredients (in each 1 mL))

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)