supress®

supress®
SPL v8
SPL
SPL Set ID ddb95436-7806-4086-af4d-18a6625b5c83
Route
oral
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) guaifenesin (50 mg) phenylephrine (2.5 mg)
Inactive Ingredients
citric acid monohydrate fd&c red no. 40 glycerin methylparaben potassium sorbate propylene glycol propylparaben water sodium citrate, unspecified form sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2011-03-29

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg


Medication Information

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 use more than directed.

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.

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

Purpose

Cough Suppressant Expectorant Nasal Decongestant

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

• mL = milliliter

• Children 2 to under 6 years of age: 1 mL

• Children under 2 years of age: do not use.

Other Information

Tamper Evident Feature: Do not use if printed 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, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg

Section 42229-5

• Cough suppressant - Dextromethorphan HBr

• Expectorant - Guaifenesin

• Nasal Decongestant - Phenylephrine HCl

PEDIATRIC DROPS

2 TO 6 YEARS

For relief of:

+ Cough

+ Chest Congestion/Mucus

+ Stuffy Nose

Sugar & Alcohol Free

Cherry Flavor

NET CONTENTS: 30 ML (1 Fl. Oz.)

Kramer Novis

Pharmaceuticals within reach of patients

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

Section 43683-2

Directions: (The following changes were made)

  • mL=milliliter
  • Children under 2 years of age: do not use.

Unclassified section (The following information has been included)

• For relief of:

  + Cough

  + Chest Congestion/Mucus

  + Stuffy Nose

Section 50565-1

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Packaging

Drug Facts

Questions Or Comments?

1-787-767-2072 You may also report serious side effects to this phone number.

Call weekdays from 8AM to 4PM AST.

Active Ingredients (in Each 1 Ml)

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Structured Label Content

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 use more than directed.

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.

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

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

• mL = milliliter

• Children 2 to under 6 years of age: 1 mL

• Children under 2 years of age: do not use.

Other Information (Other information)

Tamper Evident Feature: Do not use if printed 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, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 42229-5 (42229-5)

• Cough suppressant - Dextromethorphan HBr

• Expectorant - Guaifenesin

• Nasal Decongestant - Phenylephrine HCl

PEDIATRIC DROPS

2 TO 6 YEARS

For relief of:

+ Cough

+ Chest Congestion/Mucus

+ Stuffy Nose

Sugar & Alcohol Free

Cherry Flavor

NET CONTENTS: 30 ML (1 Fl. Oz.)

Kramer Novis

Pharmaceuticals within reach of patients

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

Section 43683-2 (43683-2)

Directions: (The following changes were made)

  • mL=milliliter
  • Children under 2 years of age: do not use.

Unclassified section (The following information has been included)

• For relief of:

  + Cough

  + Chest Congestion/Mucus

  + Stuffy Nose

Section 50565-1 (50565-1)

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

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

1-787-767-2072 You may also report serious side effects to this phone number.

Call weekdays from 8AM to 4PM AST.

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

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg

Phenylephrine HCl, 2.5 mg


Advanced Ingredient Data


Raw Label Data

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