FDA Label for Rugby Cherry Flavor
View Indications, Usage & Precautions
Rugby Cherry Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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.
Active Ingredient
Phenol 1.4%
Purpose
Oral Anesthetic/Analgesic
Uses
For the temporarily relief of occasional minor irritation, pain, sore mouth and sore throat.
Warnings
Sore throat warning: Severe or persistent sore throat or 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 6 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dosage.
Stop Use And Ask A Dentist Or Doctor If
• sore mouth symptoms do not improve in 7 days• irritation, pain or redness persists or worsens• swelling, rash or fever develops
If Pregnant Or Breast-Feeding,
ask a doctor before use.
Keep Out Of Reach Of Children.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Adults and children 12 years of age and older• apply to affected area (one spray)• allow to remain in place for at least 15 seconds, then spit out• use every 2 hours as directed by a doctor or dentist
• Children under 12 years of age: should be supervised in the use of this product• Children under 6 years of age, Ask a doctor or dentist
Other Information
• Store at room temperature.• Check expiration date before using.
Inactive Ingredients
FD&C Red No. 40, flavor, glycerin, purified water, sucralose.
Questions Or Comments?
1-800-645-2158
Principal Display Panel
*Compare to the active ingredient in CHLORASEPTIC®
NDC# 0536-1228-58
Rugby®
SUGAR-FREE
CHERRY Phenaseptic
Oral Anesthetic/Analgesic
For Relief of Minor
Sore Throat Pain
Phenol 1.4%
Naturally and Artificially Flavored
Aspirin Free
Sugar Free
6 FL OZ (177 mL)
*This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Package Label
Rugby Sore Throat Spray Cherry Flavor
* Please review the disclaimer below.