SORE THROAT CHERRY- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). 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. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When using this product,

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

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

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

• adults and children 6 years of age and older
  • apply to affected area (one spray)
  • allow to remain in place for at least 15 seconds, then spit out
  • use every 2 hours as directed by a doctor or dentist
• children under 12 years of age should be supervised in the use of this product
• children under 6 years of age, consult a doctor or dentist

Other information

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

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®*

Sore Throat Spray

Phenol/Oral Anesthetic

• Relieves Sore Throat
• Aspirin Free
• Sugar Free
• Alcohol 0.10%

CHERRY

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105

Package Label

FAMILY WELLNESS Sore throat Spray Cherry Flavor

INGREDIENTS AND APPEARANCE

SORE THROAT  CHERRY
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-376
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: 55319-376-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2014

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

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)