Cough Drops
FDA Label NDC 83698-001

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 Cough Drops (NDC 83698-001). 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, purpose, use, warnings, do not use, stop use, keep oot of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Stop Use

→ Keep Oot Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions

→ Principal Display Panel

Active Ingredient

Menthol 0.18%

Purpose

cough suppressant,oral anesthetic

Use

Cough due to cold

Occasional minor imtation or sore throat

Warnings

Sore throat warning: If sore throat is severe,persists for more than 2 days,is accompanied or follow headache,rash,swelling,nausea,or vomiting,consult a doctor promptly. These may be serious.

Do Not Use

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

Stop Use

Stop use and ask a doctor if:
1,cough persists for more than 1 week,tends to recur,
or is accompained by fever,rash,or persistent headache.These could be signs of a serius condition.

2, sore mouth does not improve in 7 days

3,irritation, pain, or redness persists or worsens.