G-supress Dx

G-supress Dx
SPL v7
SPL
SPL Set ID 5dd44337-f3aa-4e73-a206-4a29850a2f7c
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

Description

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

Purpose

Cough Suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 5 mg 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 hay fever or other upper respiratory allergies (allergic rhinitis)

• cough due to minor throat and bronchial irritation as may occur with the common cold

Section 42229-5

PEDIATRIC DROPS

2 to 6 years

Compare to Suppress® DX

By the makers of Suppress® DX

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

Cherry Flavor

Sugar & Alcohol FREE

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

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,

San Juan, PR 00917

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

Section 43683-2

Drections: (The following changes were made)

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

Unclassified section (The following information has been included)

  • PEDIATRIC DROPS
  • 2 to 6 years
  • Kramer Novis

    Pharmaceuticals within reach of patients
  • RETAIN CARTON FOR FULL PRESCRIBING INFORMATION
Section 50565-1

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

Purposes

Cough Suppressant

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 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.

Packaging

Directions

do not use more than 6 doses in any 24-hour period

• repeat every 4 hours

• mL = milliliter

• 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: do not use.

Drug Facts

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

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

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

Section 42229-5 (42229-5)

PEDIATRIC DROPS

2 to 6 years

Compare to Suppress® DX

By the makers of Suppress® DX

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

Cherry Flavor

Sugar & Alcohol FREE

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

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,

San Juan, PR 00917

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

Section 43683-2 (43683-2)

Drections: (The following changes were made)

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

Unclassified section (The following information has been included)

  • PEDIATRIC DROPS
  • 2 to 6 years
  • Kramer Novis

    Pharmaceuticals within reach of patients
  • RETAIN CARTON FOR FULL PRESCRIBING INFORMATION
Section 50565-1 (50565-1)

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

Purposes

Cough Suppressant

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 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.

Packaging

Directions

do not use more than 6 doses in any 24-hour period

• repeat every 4 hours

• mL = milliliter

• 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: do not use.

Drug Facts

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

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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