SORE THROAT MENTHOL- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by Publix Supermarkets, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation

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 adminster to children under 3 years of age unless directed by a doctor.

When using this product,

do not exceed recommended dose.

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 health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults and children 6 years 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, consult a doctor or dentist

Other information

• store between 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

D&C green #5, D&C yellow #10, FD&C green #3, glycerin, menthol, purified water, saccharin sodium anhydrous

Principal Display Panel

Menthol

Sore Throat Spray

Phenol 1.4%

Oral Anesthetic/Analgesic

Fast-acting, long-lasting

Relief of minor sore throat and mouth pain

FL OZ (mL)

*Compare to active ingredient in Chloraseptic®

*This product is not manufactured or distributed by Prestige Brands, distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL  AROUND CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811   

publix.com 1-888-267-3037

Package Label

Publix Sore Throat Spray

INGREDIENTS AND APPEARANCE

SORE THROAT  MENTHOL
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-377
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
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-377-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/30/2014

Labeler - Publix Supermarkets, Inc. (006922009)