Defensol-ito Solution

Defensol-ito Solution
SPL v8
SPL
SPL Set ID a7c7a60d-d49f-4239-92f7-714eac7eb0c5
Route
ORAL
Published
Effective Date 2021-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (4 mg) Guaifenesin (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Corn Syrup Fd&c Yellow No. 6 Glycerin Guar Gum Menthol Methylparaben Propylene Glycol Propylparaben Citric Acid Monohydrate Saccharin Sodium Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Active Ingredient  (in each 1 mL, dropperful)                                       Purpose Dextromethorphan 4 mg............................................................................Cough Suppressant Guiafenesin 50 mg............................................................................Expectorant Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant


Medication Information

Warnings and Precautions

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 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.

Ask a doctor before use if your child has

  • heart disease
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with asthma
  • high blood pressure 
  • diabetes

When using this product, do not use more than directed

Stop use and ask doctor if

  • your child gets nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, comes back, or is accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.

Indications and Usage

Uses temporarily relives these symptoms occuring with cold:

  • nasal congestion
  • cough due to minor throat and bronchial irriatation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Dosage and Administration

Directions

  • do not use more than  doses in any 24-hour period
  • repeat every 4 hours
  • choose dosage by weight (if weight is not known, choose by age)
  • measure with the dosing device provided. Do not use with any other device.

Age                              Weight                 Dose

2 to under 6 years        24-47 Lbs           1 mL

under 2 years               under 24 Lbs       ask  as doctor

Description

Active Ingredient  (in each 1 mL, dropperful)                                       Purpose Dextromethorphan 4 mg............................................................................Cough Suppressant Guiafenesin 50 mg............................................................................Expectorant Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant

Section 50565-1

Keep ot of reach of children. In case of accidental overdose, get medical help or contact  a Poison Control Center right away.

Section 51727-6

Inactive ingradients

citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water

Section 51945-4

Section 53413-1

Questions? call  1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 55105-1

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredient (in each 1 mL, dropperful)                                       Purpose

Dextromethorphan 4 mg............................................................................Cough Suppressant

Guiafenesin 50 mg............................................................................Expectorant

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


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relives these symptoms occuring with cold:

  • nasal congestion
  • cough due to minor throat and bronchial irriatation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Dosage and Administration (34068-7)

Directions

  • do not use more than  doses in any 24-hour period
  • repeat every 4 hours
  • choose dosage by weight (if weight is not known, choose by age)
  • measure with the dosing device provided. Do not use with any other device.

Age                              Weight                 Dose

2 to under 6 years        24-47 Lbs           1 mL

under 2 years               under 24 Lbs       ask  as doctor

Warnings and Precautions (34071-1)

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 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.

Ask a doctor before use if your child has

  • heart disease
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with asthma
  • high blood pressure 
  • diabetes

When using this product, do not use more than directed

Stop use and ask doctor if

  • your child gets nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, comes back, or is accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.

Section 50565-1 (50565-1)

Keep ot of 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 ingradients

citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? call  1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 55105-1 (55105-1)

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredient (in each 1 mL, dropperful)                                       Purpose

Dextromethorphan 4 mg............................................................................Cough Suppressant

Guiafenesin 50 mg............................................................................Expectorant

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


Advanced Ingredient Data


Raw Label Data

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