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  5. Label Information: Cepacol Extra Strength Sore Throat Honey Lemon

FDA Label for Cepacol Extra Strength Sore Throat Honey Lemon

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. METHEMOGLOBINEMIA WARNING
    5. ALLERGY ALERT
    6. SORE THROAT WARNING
    7. STOP USE AND ASK A DOCTOR OR DENTIST IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 16 LOZENGE BLISTER PACK CARTON

Cepacol Extra Strength Sore Throat Honey Lemon Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Do not exceed recommended dosage.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England


Otc - Purpose



Active ingredients (in each lozenge)Purposes
Benzocaine 15 mgOral pain reliever
Menthol 2.6 mgOral pain reliever

Uses



Temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Methemoglobinemia Warning



Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 any other 'caine' anesthetics.

Sore Throat Warning



  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use

Other Information



  • store between 20-25°C (68-77°F)
  • protect contents from humidity

Inactive Ingredients



D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose


Questions?



Call 1-866-682-4639

You may also report side effects to this phone number.


Principal Display Panel - 16 Lozenge Blister Pack Carton



NDC 63824-732-16

READ ALL INFORMATION

Cēpacol®
EXTRA STRENGTH*

1 LOZENGE
EVERY
2
hours

#1
DOCTOR
RECOMMENDED†

SORE THROAT

Benzocaine 15 mg • Menthol 2.6 mg | Oral Pain Reliever

* Please review the disclaimer below.