FDA Label for Cold Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cold Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each lozenge)
Zincum Gluconicum 2X (13.4 mg)
Otc - Purpose
Purpose
Cold Relief
Indications & Usage
Uses
reduces nasal congestion
Warnings
Warnings
Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc or any of the other ingredients in this product
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are now taking minocycline, doxycycline, tetracycline or are on coumadin therapy; zinc treatment may inhibit the absorption of these medicines
Otc - When Using
When using this product
to avaid minor stomach upset, do not dissolve lozenges on an empty stomach
avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking, as they may diminish effectiveness
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 7 days or are accompanied by a fever
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 reach of children.
Dosage & Administration
Directions
adults and children 12 years and over
for best results, begin treatment at start of symptoms (within 24 - 48 hours of onset)
completely dissolve lozenges in mouth. (Do not swallow whole. Do not chew.)
repeat every 2 - 4 hours as needed until symptoms subside
do not exceed 6 lozenges for adults and 4 lozenges for children ages 12 - 17 in a 24 hour period
for children under 12 years of age, consult a health professional prior to use
Other Safety Information
Other information
not formulated to be effective for treatment of influenza or allergies
store in a cool dry place after opening
contains soy
no artificial colors or preservatives
Inactive Ingredient
Inactive ingredients: Corn starch, corn syrup, glycine, medium chain triglycerides, natural flavors, purified water, soybean oil and sucrose.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST
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