Rugby Sugar-free Cherry Phenaseptic

Rugby Sugar-free Cherry Phenaseptic
SPL v7
SPL
SPL Set ID 3d668c78-8130-45d4-bcb7-dddcb2fbe7a3
Route
ORAL
Published
Effective Date 2019-04-17
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 Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-05

Description

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%

Uses

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

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 a doctor.

Directions
  • Adults and children 12 years 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 as directed by a doctor or dentist
  • Children under 12 years of age: should be supervised in the use of this product
  • Children under 6 years of age, Ask a doctor or dentist
Package Label
Active Ingredient

Phenol 1.4%

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

FD&C Red No. 40, flavor, glycerin, purified water, sucralose.

Questions Or Comments?

1-800-645-2158

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®

NDC# 0536-1228-58

Rugby ®

SUGAR-FREE

CHERRY Phenaseptic

Oral Anesthetic/Analgesic

For Relief of Minor

Sore Throat Pain

Phenol 1.4%

Naturally and Artificially Flavored

Aspirin Free

Sugar Free

6 FL OZ (177 mL)

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

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 (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or doctor 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

Uses

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

Purpose

Oral Anesthetic/Analgesic

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 a doctor.

Directions
  • Adults and children 12 years 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 as directed by a doctor or dentist
  • Children under 12 years of age: should be supervised in the use of this product
  • Children under 6 years of age, Ask 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)

FD&C Red No. 40, flavor, glycerin, purified water, sucralose.

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®

NDC# 0536-1228-58

Rugby ®

SUGAR-FREE

CHERRY Phenaseptic

Oral Anesthetic/Analgesic

For Relief of Minor

Sore Throat Pain

Phenol 1.4%

Naturally and Artificially Flavored

Aspirin Free

Sugar Free

6 FL OZ (177 mL)

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

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 (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or doctor If (Stop use and ask a dentist or doctor 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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