Chloraseptic Max Lozenges - Wild Berries

Chloraseptic Max Lozenges - Wild Berries
SPL v3
SPL
SPL Set ID edd12a2d-aa27-4f15-9ce6-862e4b6144c4
Route
ORAL
Published
Effective Date 2025-01-23
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 DRUG Active Since 2010-08-01

Description

Drug Facts

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth

Section 42229-5

Drug Facts

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

∙ pale, gray, or blue colored skin (cyanosis)

∙ headache

∙ rapid heart rate

∙ shortness of breath

∙ dizziness or lightheadedness

∙ fatigue or lack of energy

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.

If a skin reaction occurs, stop use and seek medical help right away.

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 give to children under 6 years of age unless directed by a doctor.

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

  • Children under 6 years of age: Do not use.
Do Not Use

∙ for teething

∙ in children under 6 years of age

Questions?

1-800-552-7932 C hloraseptic.com

Other Information
  • Store between 15 - 30C (59 - 86F)

  • Protect from moisture

  • Check expiration date before using
Active Ingredients

(in each lozenge)

Benzocaine 15 mg

Inactive Ingredients

corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, natural & artificial flavors, propylene glycol, soy lecithin, sucrose, water

Principal Display Panel

Chloraseptic® Max

SORE THROAT

15 LOZENGES WILD BERRIES

     

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, 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

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth

Section 42229-5 (42229-5)

Drug Facts

Purpose

Oral pain reliever

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

∙ pale, gray, or blue colored skin (cyanosis)

∙ headache

∙ rapid heart rate

∙ shortness of breath

∙ dizziness or lightheadedness

∙ fatigue or lack of energy

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.

If a skin reaction occurs, stop use and seek medical help right away.

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 give to children under 6 years of age unless directed by a doctor.

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

  • Children under 6 years of age: Do not use.
Do Not Use (Do not use)

∙ for teething

∙ in children under 6 years of age

Questions?

1-800-552-7932 C hloraseptic.com

Other Information
  • Store between 15 - 30C (59 - 86F)

  • Protect from moisture

  • Check expiration date before using
Active Ingredients

(in each lozenge)

Benzocaine 15 mg

Inactive Ingredients

corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, natural & artificial flavors, propylene glycol, soy lecithin, sucrose, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Chloraseptic® Max

SORE THROAT

15 LOZENGES WILD BERRIES

     

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, 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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