Sore Throat Relief by Western Family Foods, Inc. Drug Facts

Sore Throat Relief by

Drug Labeling and Warnings

Sore Throat Relief by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SORE THROAT RELIEF- phenol liquid 
Western Family Foods, Inc.

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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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 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

D&C green #5, D&C yellow #10, FD&C green #3, glycerin, menthol, purified water, saccharin sodium

Questions or comments?

Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Soothing Menthol Flavor

Sore Throat Relief

Phenol/Oral Anesthetic Spray

Instant Acting

Relieves Sore Throat

Fast Relief!

Alcohol Free

Aspirin Free

Sugar Free

Compare to Chloraseptic® Active Ingredient*

*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.

Proudly Distributed by Western Family Foods, Inc.

P.O Box 4057 Portland, OR 97208 USA

www.westernfamily.com

Package Label

Western Famly Sore Throat Relief Spray

 

SORE THROAT RELIEF 
phenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-377
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
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-377-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2014	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	06/30/2014	12/31/2019

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: 175b0923-6b9d-4b05-b8c7-1038bdbb545d

34390-5

Set id: 5d40f113-a071-4c25-8b6a-05d5c6f29282

Version: 3

Effective Time: 20181228

 

Western Family Foods, Inc.