Adult Long Lasting-cough Relief
FDA Label NDC 68016-026

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium Llc for the product Adult Long Lasting-cough Relief (NDC 68016-026). 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 active ingredient(s), purpose, use(s), warnings, ask a doctor before use if, stop use and ask doctor if, pregnancy/breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Dextromethorphan HBr, USP 15 mg 

Purpose

Cough Suppressant 

Use(S)

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings


DO NOT USEYou 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.

 

Ask A Doctor Before Use If

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

Stop Use And Ask Doctor If

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

Pregnancy/Breastfeeding

Ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

  • do not take more than 8 liquidgels in any 24-hour period
  • adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed 
  • children under 12 years: ask a doctor

Storage

  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
  • use by expiration date on package

Inactive Ingredients

Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

Principal Display Panel

CARTON LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for upto 8 hours
Non-drowsy
Non-Narcotic formula

20 softgels

Dex-cdc-ct-20sfg (Dex Ct)

Dex-cdc-ct-20sfg (Dex Ct)





BOTTLE LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for about 8 hours
Non-Drowsy
Non-Narcotic Formula

20 Softgels

Dex-cdc-bt-20sfg (Dex Bt)

Dex-cdc-bt-20sfg (Dex Bt)



* Please review the disclaimer below.