Chloraseptic Childrens Sore Throat Spray Cherry

Chloraseptic Childrens Sore Throat Spray Cherry
SPL v2
SPL
SPL Set ID 38ff6922-1abe-4fa9-a74e-ede604f707b5
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Water Sodium Chloride Sodium Citrate, Unspecified Form Saccharin Sodium Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-20

Description

Drug Facts _________________________________________________

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Drug Facts _________________________________________________

Uses

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

Section 42229-5

Drug Facts _________________________________________________

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 give to children under 3 years of age unless directed by a doctor.

Directions
  • Adults and children 3years 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 or as directed by a doctor or dentist

  • Children under 12 years of age should be supervised in the use of this product

  • Children under 3 years of age, consult a doctor or dentist
Active Ingredient

Phenol 1.4%

Other Information
  • store between 20°-25°C (68°- 77°F)

  • do not refrigerate

  • Check expiration date before using
Inactive Ingredients

FD&C red #40, flavor, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin , sucralose

Principal Display Panel

Chloraseptic

children’s

Sore Throat

6 FL OZ (177 mL) SPRAY

When Using This Product,

do not exceed recommended dose.

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 (1-800-222-1222) right away.

Stop Use and Ask A Doctor Or Dentist 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

Uses

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

Section 42229-5 (42229-5)

Drug Facts _________________________________________________

Purpose

Oral pain reliever

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 give to children under 3 years of age unless directed by a doctor.

Directions
  • Adults and children 3years 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 or as directed by a doctor or dentist

  • Children under 12 years of age should be supervised in the use of this product

  • Children under 3 years of age, consult a doctor or dentist
Active Ingredient (Active ingredient)

Phenol 1.4%

Other Information (Other information)
  • store between 20°-25°C (68°- 77°F)

  • do not refrigerate

  • Check expiration date before using
Inactive Ingredients (Inactive ingredients)

FD&C red #40, flavor, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin , sucralose

Principal Display Panel

Chloraseptic

children’s

Sore Throat

6 FL OZ (177 mL) SPRAY

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

do not exceed recommended dose.

Keep Out of Reach of Children. (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 (1-800-222-1222) right away.

Stop Use and Ask A Doctor Or Dentist If (Stop use and ask a doctor or dentist 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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