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

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. 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.

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

Package Label

FAMILY WELLNESS 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, glycerin, flavor, purified water, saccharin sodium

Questions Or Comments?

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

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

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

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. 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.

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

Package Label

FAMILY WELLNESS 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, glycerin, flavor, purified water, saccharin sodium

Questions Or Comments? (Questions or comments?)

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

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

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

[{"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "1.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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. 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.", "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", "Package Label": "FAMILY WELLNESS 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, glycerin, flavor, purified water, saccharin sodium", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "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", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information