drug facts

drug facts
SPL v5
SPL
SPL Set ID 7806fac7-736e-44b0-baa2-42feb7237417
Route
oral
Published
Effective Date 2024-03-27
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 2014-06-30

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%


Medication Information

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer 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 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 6 years of age, consult a doctor or dentist
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

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

Description

Phenol 1.4%

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®*

Sore Throat Spray

Phenol/Oral Anesthetic

  • Relieves Sore Throat
  • Aspirin Free
  • Sugar Free
  • Alcohol 0.10%

CHERRY

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:

MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105

Package Label
FAMILY WELLNESS Sore throat Spray Cherry Flavor
Active Ingredient

Phenol 1.4%

Questions Or Comments?

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

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
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

Structured Label Content

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer 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 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 6 years of age, consult a doctor or dentist
Other Information (Other information)
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®*

Sore Throat Spray

Phenol/Oral Anesthetic

  • Relieves Sore Throat
  • Aspirin Free
  • Sugar Free
  • Alcohol 0.10%

CHERRY

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:

MIDWOOD BRANDS, LLC

10611 MONROE RD,

MATTHEWS, NC 28105

Package Label
FAMILY WELLNESS Sore throat Spray Cherry Flavor
Active Ingredient (Active ingredient)

Phenol 1.4%

Questions Or Comments? (Questions or comments?)

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

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)
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

Advanced Ingredient Data


Raw Label Data

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