Agc-biospressdx 230

Agc-biospressdx 230
SPL v5
SPL
SPL Set ID b3b9c298-4524-4ba7-a831-3bf3c2950e27
Route
ORAL
Published
Effective Date 2018-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-01

Description

Active Ingredients (in each 1mL)                   Purpose Dextromethorphan HBr, 5 mg ................................. Cough Suppressant Guaifenesin, 50 mg ................................................ Expectorant Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings:



Do not exceed recommended dosage.

  • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

Dosage and Administration

Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

Age

Dose

Children 2 to under 6 years of age

1 mL every 4 hours

Children under 2 years of age

Consult a doctor

Description

Active Ingredients (in each 1mL)                   Purpose Dextromethorphan HBr, 5 mg ................................. Cough Suppressant Guaifenesin, 50 mg ................................................ Expectorant Phenylephrine HCl, 2.5 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 right away.

Section 50570-1
  • Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Do not givethis product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
  • Stop use and ask a doctor:
  • A persistent cough may be a sign of a serious condition;
  • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Section 51727-6

Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1

Questions or comments?1-305-403-3788

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 1mL)                   Purpose

Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

Guaifenesin, 50 mg ................................................ Expectorant

Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant






Structured Label Content

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

Dosage and Administration (34068-7)

Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

Age

Dose

Children 2 to under 6 years of age

1 mL every 4 hours

Children under 2 years of age

Consult a doctor

Warnings and Precautions (34071-1)

Warnings:



Do not exceed recommended dosage.

  • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.

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 50570-1 (50570-1)
  • Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Do not givethis product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
  • Stop use and ask a doctor:
  • A persistent cough may be a sign of a serious condition;
  • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-305-403-3788

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each 1mL)                   Purpose

Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

Guaifenesin, 50 mg ................................................ Expectorant

Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant






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