Caring Mill Cough Drops Cherry Lozenge
FDA Label NDC 83698-421
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiamen Kang Zhongyuan Biotechnology Co., Ltd. for the product Caring Mill Cough Drops Cherry (NDC 83698-421). 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 lozenge), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Lozenge)
Menthol 5.8 mg
Purposes
Cough suppressant/oral anesthetic
Uses
temporarily relieves:
• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat
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 a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
When using this productdo not exceed recommended dosage
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. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
Otc - Keep Out Of Reach Of Children
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
cherry flavor, corn syrup, eucalyptus oil, FD&C blue 2, FD&C red 40, soy lecithin, sucralose, sucrose, water.
Questions Or Comments?
Call +1-866-306-9136.
You may also report concerns to this phone number.
Monday to Friday, 9 AM - 5 PM Eastern Time
Other
Resealable Bag
Value Size
†COMPARE TO THE ACTIVE INGREDIENT OF HALLS
®
Cough Drops
CHERRY
√ Soothing Drops
√ Temporarily Relieves Cough
√ Gluten Free
√ Dairy Free
Close Bag To Maintain Freshness
Contains 10 calories per lozenge
Distributed by:
FSA Store Inc.
5473 Blair Rd
Suite 100
PMB 24308
Dallas, TX 75231
MADE IN CHINA
TAMPER EVIDENT: DO NOT USE IF PACKAGING IS TORN OR DAMAGED.
†This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®
CHOKING HAZARD:
• SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.
• CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.
Packaging
* Please review the disclaimer below.