Otc - Active Ingredient
Active ingredient
- Menthol 1.1 mg
Herbal Cough Drops Pastille
FDA Label NDC 79481-9968
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Herbal Cough Drops (NDC 79481-9968). 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:
- coug as may occur with a cold
- occasional minor irritation and sore throat
Indications & Usage
Uses temporarily relieves:
- coug as may occur with a cold
- occasional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: Severe, persistent sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.
Otc - Ask Doctor
Stop and consult a doctor if
- Cough persists for more than 7 days, tends to recur, or is accompanid 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.
Otc - Stop Use
Stop and consult a doctor if
- Cough persists for more than 7 days, tends to recur, or is accompanid 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 6 years: as a doctor
Other Safety Information
- Store in a cool and dry place
- 10 calories per drop
Inactive Ingredient
caramel color, blend of herbs extract (elderflower, horehound, hyssop, lemon balm, liden flowers, mallow, peppermint, sage, thyme, wild thyme), glucose syrup, natural flavors, sucrose.
Otc - Questions
Questions? or to report and adverse event call: 1-833-552-1767
Recent Major Changes
- Indications and Usage
- Dosage and Administration
- Contraindications
- Warnings and Precautions
- Inactive ingredients
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