Sore Throat Spray Drug Facts

Sore Throat Spray Drug Facts
SPL v7
SPL
SPL Set ID af661ef0-cdc3-4146-8ae5-59795aa49650
Route
ORAL
Published
Effective Date 2015-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
D&c Green No. 5 D&c Yellow No. 10 Fd&c Green No. 3 Glycerin Water Sucralose

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-31

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
  •  
    Adults and children 6 years 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
  •  
    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
Active Ingredient

Phenol 1.4%

Other Information
  • Store at room temperature
  • Check expiration date before using
Inactive Ingredients

D&C Green #5, D&C Yellow #10, FD&C Green #3, flavor, glycerin, purified water, sucralose

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®*

Sore Throat Relief

Menthol Flavor

Fast acting relief of Minor Sore Throat and Mouth Pain

Phenol/Oral Anesthetic

Sugar-Free

Aspirin-Free

Gluten-Free

Alcohol-Free

6 FL OZ (177 mL)

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

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

DISTRIBUTED BY:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)


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
  •  
    Adults and children 6 years 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
  •  
    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
Active Ingredient (Active ingredient)

Phenol 1.4%

Other Information (Other information)
  • Store at room temperature
  • Check expiration date before using
Inactive Ingredients (Inactive ingredients)

D&C Green #5, D&C Yellow #10, FD&C Green #3, flavor, glycerin, purified water, sucralose

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®*

Sore Throat Relief

Menthol Flavor

Fast acting relief of Minor Sore Throat and Mouth Pain

Phenol/Oral Anesthetic

Sugar-Free

Aspirin-Free

Gluten-Free

Alcohol-Free

6 FL OZ (177 mL)

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

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

DISTRIBUTED BY:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

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)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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