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Sore Throat

Dosage form: spray
Ingredients: PHENOL 1.4g in 100mL
Labeler: P & L Development, LLC
NDC Code: 49580-4506

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient(s)

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Use(s)

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.

When Using

When using this product: Do not use more than directed

Stop Use

Stop use and ask doctor if:

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

If Pregnant or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions
  • apply to affected area
  • use every 2 hours
  • allow to remain in place for at least 15 seconds, then spit out

AgeDose
adults and children's 12 years or older..............for each application, spray 5 times
children 3 years to 12 years................................should be supervised in use of this product for each application, spray 3 times
children under 3 years.........................................ask a doctor or dentist

Other Information
  • Store at controlled room temperature

Inactive Ingredients

flavor, glycerin, green 3, green 5, purified water, saccharin sodium, yellow 10

Principal Display Panel

Aaron Brands

Sore Throat Spray

Menthol

Phenol, Oral Anesthetic

Instant Acting

Relieves Sore Throat

Compare to Active Ingredient in Chloraseptic

Alcohol Free

Aspirin Free

Sugar Free

6 FL OZ (177 mL)

SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-4506
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
SACCHARIN SODIUM 
FD&C GREEN NO. 3 
D&C GREEN NO. 5 
D&C YELLOW NO. 10 
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOL (Menthol Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-4506-6177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/01/200902/28/2018
Labeler - P & L Development, LLC (101896231)

Revised: 05/2017
 
P & L Development, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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