SORE THROAT READYINCASE- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. 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 the 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 active ingredient in Chloraseptic®*

Sore Throat Spray

Phenol

Oral anesthetic

• aspirin free
• sugar free

alcohol 0.10%

Cherry flavor

FL OZ (mL)

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

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

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

ReadyInCase Sore Throat Spray

INGREDIENTS AND APPEARANCE

SORE THROAT  READYINCASE
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0376
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		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0376-6	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	11/30/2014

Labeler - P & L Development, LLC (101896231)