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Sore Throat Menthol by Publix Supermarkets, Inc.

Medically reviewed on May 7, 2018

Dosage form: spray
Ingredients: PHENOL 1.4g in 100mL
Labeler: Publix Supermarkets, Inc.
NDC Code: 56062-377

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.

Drug Facts

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 by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or adminster 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
  • 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 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 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

D&C green #5, D&C yellow #10, FD&C green #3, glycerin, menthol, purified water, saccharin sodium anhydrous

Principal Display Panel

Menthol

Sore Throat Spray

Phenol 1.4%

Oral Anesthetic/Analgesic

Fast-acting, long-lasting

Relief of minor sore throat and mouth pain

FL OZ (mL)

*Compare to active ingredient in Chloraseptic®

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

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

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811   

publix.com 1-888-267-3037

Package Label

Publix Sore Throat Spray

SORE THROAT  MENTHOL
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-377
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
D&C GREEN NO. 5 
GLYCERIN 
WATER 
SACCHARIN SODIUM 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
MENTHOL, UNSPECIFIED FORM 
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-377-06177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/30/2014
Labeler - Publix Supermarkets, Inc. (006922009)

 
Publix Supermarkets, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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