THROAT BALM CARAMEL PECTIN- pectin lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ricola USA Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Oral demulcent Uses temporarily relieves: occasional minor irritation and pain associated with - sore mouth - sore throat

Authorization status:

OTC monograph not final

Summary of Product characteristics

THROAT BALM CARAMEL PECTIN- PECTIN LOZENGE
RICOLA USA 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._
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RICOLA THROAT BALM CARAMEL PECTIN
ACTIVE INGREDIENT (IN TWO DROPS)
Pectin 7.6 mg
PURPOSE
Oral demulcent
USES temporarily relieves:
occasional minor irritation and pain associated with
sore mouth
sore throat
WARNINGS
DO NOT USE
​in children under 6 years of age unless directed by a doctor.
STOP USE AND ASK A DOCTOR IF
sore throat is severe, persists for more than 2 days, or is
accompanied by fever,
headache, rash, nausea, or vomiting.
sore mouth symptoms do not improve in 7 days.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
adults and children 6 years and older: dissolve 2 drops (one at a
time) slowly in the
mouth. Do not bite or chew. Repeat every 2 hours as needed or as
directed by a
doctor
children under 6 years: ask a doctor
OTHER INFORMATION
protect from heat and moisture
INACTIVE INGREDIENTS: Caramel sugar syrup; cocoa butter; emulsifier
(sunflower
lecithin), extracts of bee balm, Ricola herb mixture (elder,
horehound, hyssop, lemon
balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and
rooibos; glucose
syrup; glucose-fructose syrup; honey; humectant (glycerine); natural
flavoring (caramel,
echinacea purpurea fresh plant pressed juice powder, honey, menthol,
peppermint,
vanilla); salt; sugar
THROAT BALM CARAMEL PECTIN
pectin lozenge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63667-301
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)
PECTIN
3.8 mg
Ricola USA Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SUCROSE CARAMEL (UNII: D8GMM4517Q)
PRODUCT CHARACTERISTICS
COLOR
brown
SCORE
no score
SHAPE
OVAL
SIZE
24mm
FLAVOR
CARAMEL
IMPRINT CODE
R
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCR