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  5. Label Information: Topcare Sore Throat Honey Lemon Flavor

FDA Label for Topcare Sore Throat Honey Lemon Flavor

View Indications, Usage & Precautions

Table of Contents

    1. TOPCARE SORE THROAT HONEY LEMON FLAVOR
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTHER
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. TOPCARE SORE THROAT LOZENGES HONEY LEMON FLAVOR 18 COUNT (36800-812-18)

Topcare Sore Throat Honey Lemon Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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.

Topcare Sore Throat Honey Lemon Flavor




Otc - Purpose



Active ingredients (in each lozenge)Purpose
Benzocaine 15 mgOral anesthetic
Menthol 2.6 mgOral anesthetic

Uses



temporarily relieves these symptoms:

  • occasional minor irritation, pain, sore mouth and sore throat
  • pain associated with canker sores

Otc - Do Not Use



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.


Other



Sore throat warning:

Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.


Stop Use And Ask A Doctor If



  • sore throat is severe or irritation, pain or redness persists or worsens
  • sore mouth symptom do not improve in 7 days

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 1 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: ask a doctor


Other Information



  • store at room temperature
  • protect from moisture

Inactive Ingredients



glucose syrup, honey, N A Flavoring, propylene glycol, sucrose, water, and  FD C yellow 5 (tartrazine), Soybean oil and corn starch used as processing aids.


Questions Or Comments?



1-888-423-0139


Topcare Sore Throat Lozenges Honey Lemon Flavor 18 Count (36800-812-18)



TopCare

FAST-ACTING RELIEF

Sore Throat

Lozenges

MENTHOL • BENZOCAINE

ORAL ANESTHETIC

• Fast, soothing, temporary

relief of minor sore throat

pain and Irritation

Honey Lemon Flavor

COMPARE TO CEPACOL

active ingredients

18 LOZENGES

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 ©TOPCO BSS3114

[email protected]

This product is not manufactured or distributed

by Reckftt Bencldser owner af the registered

trademark Cepacol.

TOPCAREHoneyLemonFlavor - TOPCAREHoneyLemonFlavor

TOPCAREHoneyLemonFlavor - TOPCAREHoneyLemonFlavor


* Please review the disclaimer below.