DRX CHOICE SORE THROAT MENTHOL FLAVOR- phenol spray 
RARITAN PHARMACEUTICALS 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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DRx Choice Sore Throat Spray Sugar Free

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.

DRx Choice Sore Throat Phenol
DRX CHOICE SORE THROAT  MENTHOL FLAVOR
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (clear) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-307-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/17/2022
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 9/2023
Document Id: 43529355-7d38-4bad-a740-71edddac6173
Set id: e3269b12-5c05-45a6-81f2-65d9f016c3aa
Version: 2
Effective Time: 20230902
 
RARITAN PHARMACEUTICALS INC