GOOD NEIGHBOR PHARMACY SORE THROAT- phenol spray
Amerisource Bergen

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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Amerisource Bergen Sore Throat Spray 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

D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, saccharin sodium

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN CHLORASEPTIC®

Instant Acting

Relieves Sore Throat

Sore Throat Spray

Fast Relief

GLUTEN FREE

Phenol/Oral Anesthetic

Alcohol Free

Aspirin Free

Sugar Free

MENTHOL

Sore Throat Spray Label

GOOD NEIGHBOR PHARMACY SORE THROAT
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24385-532
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	GREEN (olive;clear)	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24385-532-30	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/09/1993	02/27/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/09/1993	02/27/2014

Labeler - Amerisource Bergen (007914906)

Revised: 11/2017

Document Id: ff887b09-fa35-40d9-adaf-c079fa179bd6

Set id: 40bb47a3-e1bd-4be5-adc3-8c8b2dba4fc6

Version: 3

Effective Time: 20171129

Amerisource Bergen