Uses
- cough as may occur with a cold
- ocassional minor irritation and sore throat
Herbal Cough Drops Original Herb Pastille
FDA Label NDC 76162-061
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Herbal Cough Drops Original Herb (NDC 76162-061). 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 uses, menthol, stop and consult a doctor if, if pregnant or breast-feeding, keep out of the reach of children, questions?, when using this product, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Menthol
Active Ingredient
Menthol 4.8 mg
Stop And Consult 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 mouth symptons do not improve in 7 days, or if irritation, pain, or redness persists or worsens.
If Pregnant Or Breast-Feeding
If pregnant or breast feeding, ask a health professional before use.
Keep Out Of The Reach Of Children
Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions?
Questions? or to report an adverse event call 1-888-423-0139
When Using This Product
When using this product
- do not exceed recomended dosage
Other Information
Other information
- 10 calories per drop
- Store in a cool and dry place
Warnings
Warnings
Sore throat warning: Severe or persisten sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.
Inactive Ingredients
Back Panel (20250212 11146 Natural Herb Drop 45ct Topco Trasera)
Directions
- Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
- Children under 6 years: as a doctor
Indications & Usage Section
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
Package Label.Principal Display Panel
Frontal (20250212 11146 Natural Herb Drop 45ct Topco Frontal)
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