Family Care Cough Nighttime
FDA Label NDC 65923-625

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 Nighttime (NDC 65923-625). 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 - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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 30 mL dose cup)                             Purpose

Dextromethorphan HBr 30 mg................................Cough suppressant

Doxylamine succinate 12.5 mg.......................................Antihistamine

Otc - Purpose

Uses temporarily relieves cold symptoms: 

  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing

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 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 - Ask Doctor

Ask a doctor before use if you have

  • glaucoma
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using this product

  • excistability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Otc - Stop Use

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. A persistent cough may be a sign 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

  • take only as directed
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs

    • adults & children 12 years over: 30 mL (2 TBSP) every 6 hrs

    children 4 to under 12 years: ask a doctor

    children under 4 years: do not use

Storage And Handling

Other information

  • each 30 mL dose cup contains: sodium 7 mg
  • store at room temperature

Inactive Ingredient

Inactive ingredients

alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, glycerin, high fructose corn syrup, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin, xanthan gum

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

Package Label.Principal Display Panel

Image Description (625)

Image Description (625)

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