abc sore throat spray sugar free

abc sore throat spray sugar free
SPL v3
SPL
SPL Set ID 9d9baf58-4790-4ff4-a462-5eb70c0e80c5
Route
oral
Published
Effective Date 2023-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenol (1.4 g)
Inactive Ingredients
fd&c green no. 3 d&c green no. 5 d&c yellow no. 10 glycerin water sucralose

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2023-01-23

Purpose

Oral pain reliever

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 a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Uses

For the temporarily relieves of occasional minor irritation, pain, sore mouth, and sore throat.

Purpose

Oral pain reliever

Directions
  • Adults and children 12 year 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 or as directed by a doctor or dentist

  • Children 6 years to under 12 of age:Should be supervised in use of this product.
  • Children under 6 years: Consult a doctor or dentist
Other Information
  • Store at room temperature
  • Check expiration date before using.
Inactive Ingredients

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

Description

Phenol 1.4%

Principal Display Panel

*Compare to the active ingredient in Chloraseptic ®

NDC# 46122-749-76

SORE

THROAT

SPRAY

Phenol / Oral Pain Reliever

  • Fast Acting
  • Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

MENTHOL FLAVOR

Naturally and Artificially Flavored

6 FL OZ. (177 mL)

*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn.

Active Ingredient

Phenol 1.4%

Questions Or Comments?

1-866-467-2748

When Using This Product,

do not exceed recommended dosage.

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).

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 a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Uses

For the temporarily relieves of occasional minor irritation, pain, sore mouth, and sore throat.

Purpose

Oral pain reliever

Directions
  • Adults and children 12 year 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 or as directed by a doctor or dentist

  • Children 6 years to under 12 of age:Should be supervised in use of this product.
  • Children under 6 years: Consult a doctor or dentist
Other Information (Other information)
  • Store at room temperature
  • Check expiration date before using.
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

*Compare to the active ingredient in Chloraseptic ®

NDC# 46122-749-76

SORE

THROAT

SPRAY

Phenol / Oral Pain Reliever

  • Fast Acting
  • Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

MENTHOL FLAVOR

Naturally and Artificially Flavored

6 FL OZ. (177 mL)

*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn.

Active Ingredient (Active ingredient)

Phenol 1.4%

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product, (When using this product,)

do not exceed recommended dosage.

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).

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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