agc-biocof 249

agc-biocof 249
SPL v6
SPL
SPL Set ID 6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6
Route
oral
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg) phenylephrine (10 mg)
Inactive Ingredients
citric acid monohydrate glycerin menthol methylparaben sodium citrate propylene glycol sucralose water propylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-07-01
Description

Active Ingredients (in each 5 mL tps.)         Purpose Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant Guaifenesin.... 400 mg........................................................Expectorant Phenylephrine HCL.....10 mg...............................................Nasal Decogestant

Medication Information

Warnings and Precautions

Warnings:

Ask a doctor before use if you have:

  • Heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to an enlarged prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a  doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment or prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if:you get 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 a fever, rash or persistent headache. These could be signs of serious condition.

Active Ingredient

Active Ingredients (in each 5 mL tps.)         Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant

Phenylephrine HCL.....10 mg...............................................Nasal Decogestant



Indications and Usage

Uses

  • temporary relives cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

Dosage and Administration

DirectionsDo not exceed more than 6 doses in any 24 hours period.

Adults and children 12 years of age and over.  Take 1 teaspoonful (5 mL) every 4 hours
Children under 12 years of age.  Consult a physician

Description

Active Ingredients (in each 5 mL tps.)         Purpose Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant Guaifenesin.... 400 mg........................................................Expectorant Phenylephrine HCL.....10 mg...............................................Nasal Decogestant

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.

Section 50570-1


Do not use:

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



Section 51727-6

Inactive Ingredients:Cherry flavor, Citric Acid, Glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucralose

Section 51945-4

Section 53413-1



Questions or comments? 1-305-403-3788



Manufactured for:Advanced Generic Corporation

                          Miami, FL 33166

Section 53414-9

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

Section 55105-1

Uses:

  • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

Ask a doctor before use if you have:

  • Heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to an enlarged prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a  doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment or prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if:you get 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 a fever, rash or persistent headache. These could be signs of serious condition.

Active Ingredient (55106-9)

Active Ingredients (in each 5 mL tps.)         Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant

Phenylephrine HCL.....10 mg...............................................Nasal Decogestant



Indications and Usage (34067-9)

Uses

  • temporary relives cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

Dosage and Administration (34068-7)

DirectionsDo not exceed more than 6 doses in any 24 hours period.

Adults and children 12 years of age and over.  Take 1 teaspoonful (5 mL) every 4 hours
Children under 12 years of age.  Consult a physician

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.

Section 50570-1 (50570-1)


Do not use:

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



Section 51727-6 (51727-6)

Inactive Ingredients:Cherry flavor, Citric Acid, Glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)



Questions or comments? 1-305-403-3788



Manufactured for:Advanced Generic Corporation

                          Miami, FL 33166

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses:

  • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.207110 · Updated: 2026-03-14T23:11:59.437858