Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 9162ae27-ddbb-4336-9655-487995919de4
Route
ORAL
Published
Effective Date 2024-05-01
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 2014-08-31

Description

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%

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 that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

Directions
  • apply to affected area
  • use every 2 hours
  • allow to remain in place for at least 15 seconds, then spit out
age dose 
 adults and children 12 years and over  for each application, spray 5 times 
 children 3 to 11 years  should be supervised in use of this product for each application, spray 3 times
 children under 3 years  ask a doctor or dentist
Package Label
Quality Choice Sore Throat Spray
Active Ingredient

Phenol 1.4%

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

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

Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredient in Chloraseptic®

Sore Throat Spray

Oral anesthetic/analgesic

Phenol

Fast acting/long lasting

Alcohol 0.10%

Cherry flavor

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE F IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days
  • difficulty in breathing occurs
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.


Structured Label Content

Uses

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

Purpose

Oral Anesthetic/Analgesic

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

Directions
  • apply to affected area
  • use every 2 hours
  • allow to remain in place for at least 15 seconds, then spit out
age dose 
 adults and children 12 years and over  for each application, spray 5 times 
 children 3 to 11 years  should be supervised in use of this product for each application, spray 3 times
 children under 3 years  ask a doctor or dentist
Package Label
Quality Choice Sore Throat Spray
Active Ingredient (Active ingredient)

Phenol 1.4%

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

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

Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredient in Chloraseptic®

Sore Throat Spray

Oral anesthetic/analgesic

Phenol

Fast acting/long lasting

Alcohol 0.10%

Cherry flavor

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE F IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

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

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days
  • difficulty in breathing occurs
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.


Advanced Ingredient Data


Raw Label Data

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