Agc-biocotron Ped 261

Agc-biocotron Ped 261
SPL v5
SPL
SPL Set ID 53097e28-ff2a-4ceb-9c95-d75d7ae511b8
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 (350 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Eucalyptus Oil Glycerin Hydroxyethyl Cellulose (100 Mpa.s At 2%) Methylparaben Polyethylene Glycol, Unspecified Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

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

Active Ingredients (in each 5mL)                              Purpose Dextromethorphan HBr, 15 mg ................................. Cough Suppressant Guaifenesin, 350 mg ................................................ Expectorant Phenylephrine HCl, 10 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 persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult 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 doctor or pharmacist 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

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 are takingsedatives or tranquilizers.

Indications and Usage

Uses

  • non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
  • calms the cough control center and relieves coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
  • temporarily relieves nasal congestion due to the common cold
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Dosage and Administration

Directions:Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician

Age Dose
Adults and children 12 years of age or older 1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of age Ask a doctor

Description

Active Ingredients (in each 5mL)                              Purpose Dextromethorphan HBr, 15 mg ................................. Cough Suppressant Guaifenesin, 350 mg ................................................ Expectorant Phenylephrine HCl, 10 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 right away.

Section 51727-6

Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, 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, 15 mg ................................. Cough Suppressant

Guaifenesin, 350 mg ................................................ Expectorant

Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Uses

  • non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
  • calms the cough control center and relieves coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
  • temporarily relieves nasal congestion due to the common cold
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Dosage and Administration (34068-7)

Directions:Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician

Age Dose
Adults and children 12 years of age or older 1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of age Ask 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 persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult 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 doctor or pharmacist 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

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 are takingsedatives 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 right away.

Section 51727-6 (51727-6)

Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, 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, 15 mg ................................. Cough Suppressant

Guaifenesin, 350 mg ................................................ Expectorant

Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.732554 · Updated: 2026-03-14T23:06:08.994677