Supress Dm

Supress Dm
SPL v5
SPL
SPL Set ID 7da0611e-729c-4cf8-88f3-f8877b9f5cfa
Route
ORAL
Published
Effective Date 2025-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (50 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-02

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg

Uses

• Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold

• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Section 42229-5

COUGH SUPPRESSANT

EXPECTORANT

No sugar, dye, alcohol, aspartame or sorbitol

DECONGESTANT FREE

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

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.

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 taking this product.

Ask a doctor before use if your child has

  • 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 the recommended dosage.

Stop use and ask a doctor if

  • new symptoms occur
  • coughs 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

Children 6 to under 12 years of age

• 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor

• Children under 6, 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, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

Active Ingredients (in Each 1 Ml)

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg


Structured Label Content

Uses

• Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold

• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Section 42229-5 (42229-5)

COUGH SUPPRESSANT

EXPECTORANT

No sugar, dye, alcohol, aspartame or sorbitol

DECONGESTANT FREE

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

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.

Purpose

Cough Suppressant

Expectorant

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 taking this product.

Ask a doctor before use if your child has

  • 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 the recommended dosage.

Stop use and ask a doctor if

  • new symptoms occur
  • coughs 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

Children 6 to under 12 years of age

• 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor

• Children under 6, consult a doctor

Drug Facts

Other Information (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, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

Active Ingredients (in Each 1 Ml) (Active Ingredients (in each 1 ml))

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg


Advanced Ingredient Data


Raw Label Data

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