Family Care Cough And Cold
FDA Label NDC 65923-633

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Cough And Cold (NDC 65923-633). 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, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, 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 (in each 10 mL)                                                               Purpose

Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

Guaifenesin, USP 200 mg....................................................................Expectorant

Otc - Purpose

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.

Warnings

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or until 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 - Ask Doctor

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Otc - Stop Use

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
    •  age dose
     adults and children 12 years and over 10 mL every 4 hours
     children under 12 years do not use

Storage And Handling

Other information

  • each 10 mL contains: sodium 3 mg
  • Store at 20° to 25°C (68° to 77°F). Do not refrigerate.

Inactive Ingredient

Inactive ingredients

citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (633)

Image Description (633)

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