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

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. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

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 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
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

Description

Phenol 1.4%

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

Package Label
Active Ingredient

Phenol 1.4%

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

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.

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 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
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

Package Label
Active Ingredient (Active ingredient)

Phenol 1.4%

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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