ANGIDOL HONEY LEMON FLAVOR- benzocaine, menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Grandall Distributing Co., Inc.

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 15 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves these symptoms: - occasional minor irritation, pain, sore mouth and sore throat - pain associated with canker sores

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANGIDOL HONEY LEMON FLAVOR- BENZOCAINE, MENTHOL LOZENGE
GRANDALL DISTRIBUTING CO., INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
GRANDALL - ANGIDOL LOZENGES HONEY LEMON FLAVOR (48201-003)
ANGIDOL HONEY LEMON FLAVOR
_ACTIVE INGREDIENTS (IN EACH DROP)_
_PURPOSES_
Benzocaine 15.0 mg
Oral Anesthetic
Menthol 2.6 mg
Oral Anesthetic
USES
Temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
pain associated with canker sores
WARNINGS
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:
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.
When using this product
do not exceed recommended dosage
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
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
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 yellow 5
(tartrazine). Soybean oil and corn starch used as processing aids.
QUESTIONS OR COMMENTS?
call 1-800-344-2422
Monday-Friday, 8