GOOD SENSE SORE THROAT- phenol spray
L Perrigo Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Perrigo Sore Throat Drug Facts

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 fever, headache, rash, swelling, nausea, or 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
•: difficulty in breathing occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

•: apply to the affected area
•: allow to remain in place for at least 15 seconds, then spit out
•: use every 2 hours or as directed by a doctor or dentist

adults and children 12 years of age & older	spray 5 times for each application
children 3 to under 12 years (with adult supervision)	spray 3 times for each application
children under 3 years of age	ask a doctor or dentist

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

FD&C red no. 40, flavor, glycerin, purified water, saccharin sodium

Questions or comments?
1-800-719-9260

Principal Display Panel

Fast Relief

Sore Throat

Spray

Phenol/Oral Anesthetic

Instant Acting/Relieves Sore Throat

Cherry

Alcohol Free

Aspirin Free

Sugar Free

Compare to active ingredient of Chloraseptic®

GOOD SENSE SORE THROAT
phenol spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0113-0328
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENOL (PHENOL)	PHENOL	1.4 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40
GLYCERIN
WATER
SACCHARIN SODIUM DIHYDRATE

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0113-0328-30	177 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/06/1993

Labeler - L Perrigo Company (006013346)

Revised: 8/2012

Document Id: 36bc054e-1b90-4475-b2b0-4bc25dd77570

Set id: 36bc054e-1b90-4475-b2b0-4bc25dd77570

Version: 1

Effective Time: 20120822

L Perrigo Company