sore throat

sore throat
SPL v3
SPL
SPL Set ID 15095229-f59d-4855-b38f-a090d661860a
Route
oral
Published
Effective Date 2016-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenol (1.4 g)
Inactive Ingredients
fd&c red no. 40 glycerin water saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph not final active Since 2016-09-23

Purpose

Oral anesthetic/analgesic

Description

Phenol 1.4%


Medication Information

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Uses
  • For the temporary relief of occasional minor throat:
  • irritation 
  • pain
  • sore mouth and
  • sore throat
Purpose

Oral anesthetic/analgesic

Directions
  • Adults and children 3 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 or dentist.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 3 years of age: consult a doctor or dentist
  • Before using the first time, remove the protective neck band and its dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tilting head. Fully depress pump all the way down with a firm even stroke. Wipe nozzle dry.
Other Information
  • store at room temperature
  • check expiration date before using
  • retain carton for future reference
Inactive Ingredients

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

Description

Phenol 1.4%

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions

Active Ingredient

Phenol 1.4%

When Using This Product
  • do not exceed recommended dose
  • do not use for more than 2 days, Use only as directed
  • use of this container by more than one person may spread infection
If Pregnant Or Breast Feeding,

ask 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.

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

Structured Label Content

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Uses
  • For the temporary relief of occasional minor throat:
  • irritation 
  • pain
  • sore mouth and
  • sore throat
Purpose

Oral anesthetic/analgesic

Directions
  • Adults and children 3 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 or dentist.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 3 years of age: consult a doctor or dentist
  • Before using the first time, remove the protective neck band and its dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tilting head. Fully depress pump all the way down with a firm even stroke. Wipe nozzle dry.
Other Information (Other information)
  • store at room temperature
  • check expiration date before using
  • retain carton for future reference
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions

Active Ingredient (Active ingredient)

Phenol 1.4%

When Using This Product (When using this product)
  • do not exceed recommended dose
  • do not use for more than 2 days, Use only as directed
  • use of this container by more than one person may spread infection
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask 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.

Stop Use and Ask A Doctor Or Dentist If (Stop use and ask a doctor or dentist if)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Advanced Ingredient Data


Raw Label Data

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