RUGBY CHERRY FLAVOR- phenol spray

Rugby by

Drug Labeling and Warnings

Rugby by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

www.rugbylaboratories.com

Package Label

Rugby Sore Throat Spray Cherry Flavor

INGREDIENTS AND APPEARANCE

RUGBY  CHERRY FLAVOR
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1228
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1228-58	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/05/2019

Labeler - RUGBY LABORATORIES (079246066)