Agc-biodespdmnf 263

Agc-biodespdmnf 263
SPL v7
SPL
SPL Set ID 82528dba-e3e7-416a-935d-7b6324a83f5a
Route
ORAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Menthol Methylparaben Propylparaben Propylene Glycol Water Sucralose Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-01
Description

Active Ingredients (in each 5mL)                              Purpose Dextromethorphan HBr, 10 mg ................................. Cough Suppressant Guaifenesin, 100 mg ................................................ Expectorant Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Medication Information

Warnings and Precautions

Warnings:

Do no exceed recommended dosage

  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or a persistent headache, consult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • difficulty in urincation due to enlargment of the prostate gland unless directed by a doctor

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you aretaking sedatives or tranquilizers

Indications and Usage

Uses

  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration

Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.

Age Dose
Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age 1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor

Description

Active Ingredients (in each 5mL)                              Purpose Dextromethorphan HBr, 10 mg ................................. Cough Suppressant Guaifenesin, 100 mg ................................................ Expectorant Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Section 50565-1

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients: citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose.

Section 51945-4

Section 53413-1

Questions or comments?1-305-403-3788

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 5mL)                              Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 100 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration (34068-7)

Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.

Age Dose
Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age 1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor

Warnings and Precautions (34071-1)

Warnings:

Do no exceed recommended dosage

  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or a persistent headache, consult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • difficulty in urincation due to enlargment of the prostate gland unless directed by a doctor

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you aretaking sedatives or tranquilizers

Section 50565-1 (50565-1)

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients: citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-305-403-3788

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each 5mL)                              Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 100 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.836353 · Updated: 2026-03-14T23:06:11.878508