Exchange Select Cough Drops Lozenge
FDA Label NDC 83698-585

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xiamen Kang Zhongyuan Biotechnology Co., Ltd. for the product Exchange Select Cough Drops (NDC 83698-585). 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 drug facts, active ingredient (in each drop), uses, warnings, ask doctor before use if you have, otc - when using, stop use and ask a doctor if, keep this and all drugs out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (In Each Drop)

Menthol, 4.8 mg

Uses

temporarily relieves:

  • cough due to a cold
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2
days, is accompanied or followed by fever, headache, rash, swelling,
nausea, or vomiting, consult a doctor promptly.

Ask Doctor Before Use If You Have

  • persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep This And All Drugs Out Of The Reach Of Children.

Directions

  • adults and children 2 years and over: dissolve lozenge slowly in the
    mouth. Repeat every 2 hours as needed or as directed by a doctor
  • children under 2 years of age: ask a doctor

Other Information

  • store at room temperature.
  • keep away from excessive heat or sunlight
  • do not use if primary bag seal has been torn or broken.
  • contains: SOY

Inactive Ingredients

caramel, corn syrup, flavors, herbal extract
blend (elderflower extract, horehound extract, hyssop extract, lemon
balm extract, linden flower extract, malva sylvestris (mallow) leaf extract,
peppermint extract, sage extract, thyme extract, wild thyme extract),
soy lecithin, sucrose.

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