SORE THROAT- 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 Drug Facts

Active Ingredient(s)

Phenol 1.4%

Purpose

Oral pain reliever

Use(s)

for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore Throat Warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give 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 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

If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Directions

Adults and children 12 years of age and older:
Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out.
Use every 2 hours or as directed by a doctor or dentist.
Children 6 years to under 12 years of age: should be supervised in the use of this product.
Children under 6 years: Consult a doctor or dentist.

Other Information

Store at room temperature
Check expiration date before using.

Inactive Ingredients

FD&C Red No. 40, flavor, glycerin, purified water, sucralose

Questions or comments?

1-866-467-2748

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®

NDC# 68163-703-06

SORE THROAT SPRAY

Phenol/Oral Pain Reliever

Fast Acting

Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

NATURAL CHERRY FLAVOR

6 FL OZ (177 mL)

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Distributed by:

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

DRx Sore Throat Spray
SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-703
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 RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY (Natural Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-703-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2020
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: 2744c4a1-81af-4181-afec-439c242dc6d1
Set id: 43ce374a-824c-4034-bf04-c351b4d8015b
Version: 4
Effective Time: 20230902
 
Raritan Pharmaceuticals Inc