chloraseptic max berry lozenges

chloraseptic max berry lozenges
SPL v1
SPL
SPL Set ID 5815a5e4-9b84-43bc-bbf3-4b85596e43d6
Route
oral
Published
Effective Date 2010-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 mg) benzocaine (15 mg)
Inactive Ingredients
corn syrup fd&c blue no. 1 fd&c red no. 40 glycerin lecithin, soybean sucrose water propylene glycol

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: oval Color: red Size: 4 mm Score: 2
Marketing Status
otc monograph final active Since 2010-08-01

Purpose

Oral Anesthetic/Analgesic

Description

Drug Facts


Medication Information

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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.

Uses

Temporarily relieves:

  • occasional minor irritation, pain, sore throat and sore mouth
Purpose

Oral Anesthetic/Analgesic

Directions
  • Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

  • Children under 6 years of age: Consult a doctor or dentist.
Other Information
  • Store between 59ºF and 86ºF (15ºC - 30ºC).

  • Protect from moisture.

  • Check expiration date before using.

  • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
Inactive Ingredients

Corn Syrup, FD&C Blue #1, FD&C Red #40, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water

Description

Drug Facts

Principal Display Panel

Chloraseptic® Max

SORE THROAT FAST ACTING RELIEF

15 lozenges | Wild Berries

Questions?

1-800-552-7932 or www.chloraseptic.com

Section 42229-5

Drug Facts

Active Ingredients

(in each lozenge)

Benzocaine 15 mg

When Using This Product:

do not exceed recommended dosage.

If Pregnant Or Breast Feeding,

ask a health care professional 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 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

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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.

Uses

Temporarily relieves:

  • occasional minor irritation, pain, sore throat and sore mouth
Purpose

Oral Anesthetic/Analgesic

Directions
  • Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

  • Children under 6 years of age: Consult a doctor or dentist.
Other Information
  • Store between 59ºF and 86ºF (15ºC - 30ºC).

  • Protect from moisture.

  • Check expiration date before using.

  • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
Inactive Ingredients

Corn Syrup, FD&C Blue #1, FD&C Red #40, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Chloraseptic® Max

SORE THROAT FAST ACTING RELIEF

15 lozenges | Wild Berries

Questions?

1-800-552-7932 or www.chloraseptic.com

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients

(in each lozenge)

Benzocaine 15 mg

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 health care professional 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 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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