Cough Drops Menthol 5.4 mg/1
Menthol Cough Drops · PASTILLE · Cardinal Health 110, Inc.
Cough Drops Menthol is a pastille containing menthol cough drops at 5.4 mg/1, taken oral. Manufactured by Cardinal Health 110, Inc..
Key Facts
- Brand Name
- Cough Drops Menthol
- Generic Name
- Menthol Cough Drops
- NDC Code (Product)
70000-0638- Manufacturer
- Cardinal Health 110, Inc.
- Strength
- 5.4 mg/1
- Dosage Form
- PASTILLE
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 06/17/2023
Recall History
Bestco LLC
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Bestco, Inc.
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Temporarily relieves: Cough as may occur with a cold; occasional minor irritation and sore throat
Dosage & Administration
Directions adults and children 5 years and over dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 5 years ask a doctor
Warnings
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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious. Ask a doctor before use if you have: persistent or 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 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children.
Frequently Asked Questions
What is Cough Drops Menthol used for?
Cough Drops Menthol contains Menthol Cough Drops. It is a pastille taken oral. Consult your doctor for specific uses.
Is Cough Drops Menthol a controlled substance?
Cough Drops Menthol is not classified as a controlled substance by the DEA.
What is the generic name for Cough Drops Menthol?
The generic name for Cough Drops Menthol is Menthol Cough Drops. There are 2 other brand versions of Menthol Cough Drops.
What is the NDC code for Cough Drops Menthol 5.4 mg/1?
The NDC (National Drug Code) for Cough Drops Menthol 5.4 mg/1 is 70000-0638, listed by Cardinal Health 110, Inc..