Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID c0a47d59-3e15-453d-97a7-d626e8650862
Route
ORAL
Published
Effective Date 2024-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Alcohol Fd&c Red No. 40 Glycerin Water Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-29

Description

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%

Uses

for the temporarily relief of  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.

Directions
  • adults and children 2 years of age and older
    • apply to the 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 2 years of age, consult a doctor or dentist
Package Label
BEST CHOICE Sore Throat Spray Cherry Flavor
Active Ingredient

Phenol 1.4%

Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

alcohol, FD&C red #40, flavor glycerin,  purified water, saccharin sodium anhydrous

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient of Chloraseptic®

CHERRY FLAVOR

Sore Throat Spray

PHENOL 1.4%

ORAL ANESTHETIC/ANALGESIC

Relieves sore throat

Alcohol 0.10%

Aspirin free

Sugar free

FOR AGES 2 & OVER

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING. FOR LOT AND EXPIRATIONDATE, SEE BOTTOM OF BOTTLE KEEP CAP ON WHEN NOT IN USE.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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.

If more than used for minor mouth or throat pain ia accidentally swallowed, 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 is severe, or lasts for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • fever, headache, rash, swelling, nausea or vomiting develops

Structured Label Content

Uses

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

Purpose

Oral Anesthetic/Analgesic

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.

Directions
  • adults and children 2 years of age and older
    • apply to the 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 2 years of age, consult a doctor or dentist
Package Label
BEST CHOICE Sore Throat Spray Cherry Flavor
Active Ingredient (Active ingredient)

Phenol 1.4%

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

alcohol, FD&C red #40, flavor glycerin,  purified water, saccharin sodium anhydrous

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient of Chloraseptic®

CHERRY FLAVOR

Sore Throat Spray

PHENOL 1.4%

ORAL ANESTHETIC/ANALGESIC

Relieves sore throat

Alcohol 0.10%

Aspirin free

Sugar free

FOR AGES 2 & OVER

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING. FOR LOT AND EXPIRATIONDATE, SEE BOTTOM OF BOTTLE KEEP CAP ON WHEN NOT IN USE.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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.)

If more than used for minor mouth or throat pain ia accidentally swallowed, 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 is severe, or lasts for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • fever, headache, rash, swelling, nausea or vomiting develops

Advanced Ingredient Data


Raw Label Data

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