Agc-biozcough 251

Agc-biozcough 251
SPL v7
SPL
SPL Set ID 05e70eab-1467-4b09-991e-ef03f222e021
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Menthol Methylparaben Propylparaben Sucralose Water Propylene Glycol Sodium Citrate Citric Acid Monohydrate

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


Medication Information

Warnings and Precautions

Warnings:

Ask a doctor before use if you have:

  • cough that occurs with too much phlegm (mucus)

  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.



When using this product do not use more than directed.

Stop use and ask a doctor before use 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.







Indications and Usage



Other Information:

  • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
  • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
  • Avoid excessive heat or humidity.





Dosage and Administration

Direction: do 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

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:

Citric Acid, flavor, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1



Questions or comments?1-305-403-3788

Manufactured for: Advanced Generic Corporation

Miami, FL 33166

www.advancedgeneric.com

Section 53414-9

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

Section 55105-1


Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Section 55106-9

Active Ingredients (in each 5 mL tps.)         Purpose

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

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




Structured Label Content

Indications and Usage (34067-9)



Other Information:

  • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
  • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
  • Avoid excessive heat or humidity.





Dosage and Administration (34068-7)

Direction: do 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:

  • cough that occurs with too much phlegm (mucus)

  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.



When using this product do not use more than directed.

Stop use and ask a doctor before use 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 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:

Citric Acid, flavor, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and 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

www.advancedgeneric.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)


Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL tps.)         Purpose

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

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




Advanced Ingredient Data


Raw Label Data

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