SORE THROAT CHERRY- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. 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 accompanied with high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age.

When using this product,

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

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

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

INGREDIENTS AND APPEARANCE

SORE THROAT  CHERRY
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-5112(NDC:49348-991)
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: 68071-5112-6	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/30/2014

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-5112)