DRX CHOICE SORE THROAT MENTHOL FLAVOR- phenol spray

DRx Choice Sore Throat by

Drug Labeling and Warnings

DRx Choice Sore Throat by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenol 1.4%

Purpose

Oral pain reliever

Uses

For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by 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 6 years of age unless directed by doctor.

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor or dentist 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 doctor before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• ▪ Adults and children 12 year 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 or as directed by a doctor or dentist

• ▪ Children under 12 years of age: Should be supervised in use of this product.
• ▪ Children under 6 years of age: Ask a doctor or dentist

Other information

• Store at room temperature
• Check expiration date before using.

Inactive ingredients

FD&C Green #3, D&C Green #5, FD&C Yellow #10, flavor, glycerin, purified water, sucralose.

Questions or comments?

1-866-467-2748

Principal Display Panel

DRx Choice®

NDC# 68163-307-06

*Compare to the active ingredient in Chloraseptic®

Sore throat spray

Phenol/Oral Pain Reliever

• Fast Acting
• Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

Menthol Flavor

Naturally and Artificially Flavored

6 FL OZ. (177 mL)

*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn.

INGREDIENTS AND APPEARANCE

DRX CHOICE SORE THROAT  MENTHOL FLAVOR
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-307
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-307-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/17/2022

Labeler - RARITAN PHARMACEUTICALS INC (127602287)