Cosedal Drops Liquid
FDA Label NDC 53145-059

11 label sections · Submitted to the FDA by Menper Distributors, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Cosedal Drops (NDC 53145-059). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Dextromethorphan HBR

Guaifenesin

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Indications & Usage

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

Warnings

Do not exceed recommended dosage.

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

Otc - Do Not Use

Do not use:

  • This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

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

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

Dosage & Administration

Directions

Do not exceed 6 doses in 24 hours.

 age dose
 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 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) every 4 hours
 Children under 2 years of age consult your doctor

Other Safety Information

Other information

Store this product between 15°-30°C (59°-86°F)

Inactive Ingredient

Inactive ingredientsCitric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry falvor, sucrose, water

Otc - Questions

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

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