SMITH BROS BLACK LICORICE THROAT DROPS- pectin lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)

Available from:

Universal holdings I LLC dba Smith Brothers Company

INN (International Name):

PECTIN

Composition:

PECTIN 1.7 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Demulcent temporarily relieves - minor discomfort and protection of irritated areas in sore mouth and sore throat

Authorization status:

OTC monograph not final

Summary of Product characteristics

SMITH BROS BLACK LICORICE THROAT DROPS- PECTIN LOZENGE
UNIVERSAL HOLDINGS I LLC DBA SMITH BROTHERS COMPANY
_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._
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SMITH BROS BLACK LICORICE THROAT DROPS
SMITH BROS BLACK LICORICE THROAT DROPS
ACTIVE INGREDIENTS (PER DROP)
Pectin 1.7mg
PURPOS E
Oral Demulcent
US ES
temporarily relieves
minor discomfort and protection of irritated areas in sore mouth and
sore throat
WARNINGS
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 5 years of age unless directed by a
doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE:
persistent or chronic cough such as occurs with smoking, asthma, or
emphysema
cough accompanied by excessive phlegm (mucus).
STOP USE AND ASK A DOCTOR IF
sore throat is severe, or irritation, pain or redness lasts or
worsens.
sore mouth does not improve in 7 days.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DIRECTIONS
ADULTS AND CHILDREN 5 YEARS AND OVER
Allow 1 drop to dissolve slowly in mouth; may be repeated every two
hours or as directed by a doctor.
UNDER 5 YEARS OLD
Consult a doctor.
OTHER INFORMATION
Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F) in a
dry place
INACTIVE INGREDIENTS
FD&C blue no.2, FD&C red no.3, FD&C yellow no.6 glucose syrup,
licorice, sucrose, water
SMITH BROS BLACK LICORICE THROAT DROPS 14 DROPS (76461-915-14)
SMITH BROS BLACK LICORICE THROAT DROPS
pectin lozenge
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 46 1-9 15
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PECTIN (UNII: 8 9 NA0 2M4RX) (PECTIN - UNII:8 9 NA0 2M4RX)
PECTIN
1.7 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FD&C B