SORE THROAT CHERRY- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 49781. 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

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• sore mouth symptoms do not improve in 7 days
• difficulty in breathing occurs

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

• apply to affected area
• use every 2 hours
• allow to remain in place for at least 15 seconds, then spit out

• age: dose
• adults and children 12 years and over: for each application, spray 5 times
• children 3 to 11 years: should be supervised in use of this product for each application, spray 3 times
• children under 3 years: ask a doctor or dentist

Other information

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

Inactive ingredients

alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Chloraseptic® active ingredient*

Cherry Flavor

Sore Throat Spray

Phenol/Oral Anesthetic

Instant Acting/Relieves Sore Throat

Relief of Minor Sore Throat and Mouth Irritation

Alcohol 0.10%

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

DISTRIBUTED BY: CARDINAL HEALTH DUBLIN, OHIO 43017

CIN 4957643

www.myleader.com

1-800-200-6313

Package Label

Leader Sore Throat Spray

INGREDIENTS AND APPEARANCE

SORE THROAT  CHERRY
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-098
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
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: 49781-098-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2014	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/31/2014	12/31/2020

Labeler - Cardinal Health (Leader) 49781 (097537435)