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.

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

Section 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




Structured Label Content

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

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.

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

Section 55106-9 (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




Advanced Ingredient Data


Raw Label Data

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