drug facts

drug facts
SPL v10
SPL
SPL Set ID d1e80892-a9ef-4ff5-9577-1e89b71b02b5
Route
oral
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenol (1.5 g)
Inactive Ingredients
fd&c red no. 40 glycerin water sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-09-01

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 doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Uses

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

Purpose

Oral Anesthetic/Analgesic

Directions
  • 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.
  • Adults and children 6 years of age and older:For each application, spray 5 times.
  • Children under 12 years of ageshould be supervised in the use of this product.
  • Children under 3 years of age: Ask a doctor or dentist.
Other Information
  • Store at room temperature
  • Check expiration date before using.
Inactive Ingredients

FD&C Red # 40, flavor, glycerin, purified water, sucralose

Description

Phenol 1.4%

Active Ingredient

Phenol 1.4%

Drug Facts (continued)

Keep out of the reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Principal Display Pane

COMPARE TO the active ingredient in CHLORASEPTIC ®*

NDC 0904-6305-21

MAJOR ®

Cherry flavor

Sore Throat Spray

Relieves Sore Throat Pain

New Sprayer

SUGAR- FREE

ASPIRIN-FREE

GLUTEN-FREE

Cherry Flavor

6 FL OZ (177 mL)

Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing

Distributed By

MAJOR ®PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ®.

Questions Or Comments?

1-800-616-2471

When Using This Product

do not exceed recommended dosage.

If Pregnant Or Breast Feeding

ask a doctor before use.

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

Warnings

Sore Throat Warning:Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Uses

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

Purpose

Oral Anesthetic/Analgesic

Directions
  • 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.
  • Adults and children 6 years of age and older:For each application, spray 5 times.
  • Children under 12 years of ageshould be supervised in the use of this product.
  • Children under 3 years of age: Ask a doctor or dentist.
Other Information
  • Store at room temperature
  • Check expiration date before using.
Inactive Ingredients

FD&C Red # 40, flavor, glycerin, purified water, sucralose

Active Ingredient

Phenol 1.4%

Drug Facts (continued)

Keep out of the reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Principal Display Pane

COMPARE TO the active ingredient in CHLORASEPTIC ®*

NDC 0904-6305-21

MAJOR ®

Cherry flavor

Sore Throat Spray

Relieves Sore Throat Pain

New Sprayer

SUGAR- FREE

ASPIRIN-FREE

GLUTEN-FREE

Cherry Flavor

6 FL OZ (177 mL)

Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing

Distributed By

MAJOR ®PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ®.

Questions Or Comments? (Questions or comments?)

1-800-616-2471

When Using This Product (When using this product)

do not exceed recommended dosage.

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

ask a doctor before use.

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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