SORE THROAT RELIEF CHERRY FLAVOR- phenol spray

Sore Throat Relief by

Drug Labeling and Warnings

Sore Throat Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium. 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 that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

do not use more than directed.

Stop use and ask a 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 right away (1-800-222-1222)

Directions

•   Adults and children 6 years of age and older:
•   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

• Apply to the affected area (one spray)
• Allow to remain in place for at least 15 seconds, then spit out
• Use every 2 hours or as directed by a doctor
•   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 at room tempreature
• Check expiration date before using

Inactive ingredients

FD&C red #40, flavor, glycerin, purified water, sucralose

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®*

Sore Throat Relief

Cherry Flavor

Fast acting relief of Minor Sore Throat and Mouth Pain

Phenol/Oral Anesthetic

Sugar-Free

Aspirin-Free

Gluten-Free

Alcohol-Free

6 FL OZ (177 mL)

*This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic®.

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Distributed by:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

Package Label

INGREDIENTS AND APPEARANCE

SORE THROAT RELIEF  CHERRY FLAVOR
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-342
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: 68016-342-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/31/2014

Labeler - Chain Drug Consortium (101668460)