Otc - Active Ingredient
Active Ingredient
- Menthol 5.8 mg cough suppresant oral anesthetic
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Cough Drops Pastille
FDA Label NDC 83455-204
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. for the product Cough Drops (NDC 83455-204). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
Indications & Usage
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.
Otc - Ask Doctor
Ask a doctor before use if you have
- a severe throat accompanied by difficulty in breathing or that last more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Otc - Stop Use
Stop use and consult a doctor if
- sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 12 years and under do not use
Other Safety Information
- Store in a cool and dry place
- 5 calories per drop
- Maybe useful for diabetics on the advice of a doctor
- Excess comsuption may cause laxative effect
Inactive Ingredient
citric acid, isomalt, stevia
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Otc - Questions
Questions or comments: 1-855-423-2630
Package Label.Principal Display Panel
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