drug facts

drug facts
SPL v8
SPL
SPL Set ID add2fe1e-50f5-4273-a9f8-cf10d6cab036
Route
oral
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenol (1.4 g)
Inactive Ingredients
d&c green no. 5 glycerin water saccharin sodium d&c yellow no. 10 fd&c green no. 3 menthol

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2014-09-30 Until 2026-09-30

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%


Medication Information

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.

Uses

temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation

Purpose

Oral Anesthetic/Analgesic

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 second, 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 68-77ºF (20-25ºC). Do not refrigerate.
Inactive Ingredients

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

Description

Phenol 1.4%

Principal Display Panel

*Compare to the active ingredient in Chloraseptic® 

Sore Throat Spray

PHENOL 1.4%

ORAL ANESTHETIC/ANALGESIC

Relieves sore throat

  • Alcohol free
  • Aspirin free
  • Sugar free

MENTHOL FLAVOR

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands, Inc., 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
Active Ingredient

Phenol 1.4%

When Using This Product,

do not exceed recommended dose.

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.

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

Structured Label Content

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.

Uses

temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation

Purpose

Oral Anesthetic/Analgesic

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 second, 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 (Other information)
  • store between 68-77ºF (20-25ºC). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

*Compare to the active ingredient in Chloraseptic® 

Sore Throat Spray

PHENOL 1.4%

ORAL ANESTHETIC/ANALGESIC

Relieves sore throat

  • Alcohol free
  • Aspirin free
  • Sugar free

MENTHOL FLAVOR

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands, Inc., 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
Active Ingredient (Active ingredient)

Phenol 1.4%

When Using This Product, (When using this product,)

do not exceed recommended dose.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Stop Use and Ask A dentist Or Doctor if (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

Advanced Ingredient Data


Raw Label Data

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