SPL v1
SPL
SPL Set ID 3bb3a81d-d39a-4f79-84f1-ab0c075d7d34
Route
ORAL
Published
Effective Date 2015-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (40 mg) Guaifenesin (400 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Menthol Polyethylene Glycols Propylene Glycol Water Sodium Benzoate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-29

Description

Active ingredients (in each 10 mL)                                                               Purpose Dextromethorphan HBr, USP 20 mg............................................Cough suppressant Guaifenesin, USP 200 mg....................................................................Expectorant


Medication Information

Warnings and Precautions

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or until 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
 age  dose
 adults and children 12 years and over  10 mL every 4 hours
 children under 12 years  do not use

Dosage and Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Description

Active ingredients (in each 10 mL)                                                               Purpose Dextromethorphan HBr, USP 20 mg............................................Cough suppressant Guaifenesin, USP 200 mg....................................................................Expectorant

Section 44425-7

Other information

  • each 10 mL contains: sodium 3 mg
  • Store at 20° to 25°C (68° to 77°F). Do not refrigerate.
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • 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.
Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Section 51727-6

Inactive ingredients

citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.
Section 55106-9

Active ingredients (in each 10 mL)                                                               Purpose

Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

Guaifenesin, USP 200 mg....................................................................Expectorant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
 age  dose
 adults and children 12 years and over  10 mL every 4 hours
 children under 12 years  do not use

Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Warnings and Precautions (34071-1)

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or until 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 44425-7 (44425-7)

Other information

  • each 10 mL contains: sodium 3 mg
  • Store at 20° to 25°C (68° to 77°F). Do not refrigerate.
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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • 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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Section 51727-6 (51727-6)

Inactive ingredients

citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.
Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)                                                               Purpose

Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

Guaifenesin, USP 200 mg....................................................................Expectorant


Advanced Ingredient Data


Raw Label Data

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