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Drug Facts
Unishield Cherry Cough Lozenge
FDA Label NDC 49314-0505
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Cherry Cough (NDC 49314-0505). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each drop)
Menthol 7.6 mg
Otc - Purpose
Purpose
Antitussive (cough suppressant)/oral anesthetic
Questions or comments? 800-480-5855
Indications & Usage
Uses
Temporarily relieves
- cough as may occur with a cold or inhaled irritants
- occasional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: If sore throat is severe, persists for more
than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly. These
symptoms may be serious.
Otc - Ask Doctor
Ask a doctor before use
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Otc - Stop Use
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. These could be signs of a serious condition.
- sore mouth does not improve in 7 days
- 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 this and all drugs out of the reach of children.
Dosage & Administration
Directions
- do not use more than directed
Adults and children: (12 years and older)
Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.
Children under 12 years:
Ask a doctor
Other Safety Information
Other information
- 15 calories per drop
- store at 59°-86°F (15°-30°C)
- protect from moisture & heat
Inactive Ingredient
Inactive ingredients:
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
Package Label.Principal Display Panel
Unishield
Cough Drop
Cough Suppressant/Oral Anesthetic
50 Drops/Individually Wrapped
Cherry Flavored
Menthol 7.6 mg
Pull To Open
• Temporarily relieves sore throat and cough
• Pleasant tasting formula
• Menthol vapors ease congestion
Compare active ingredients to:
Hall®
Registered Trademark of Warner-Lambert
Individually Wrapped Cough Drops
* Please review the disclaimer below.
