BRONCOLIN HONEY LEMON- menthol lozenge

BRONCOLIN by

Drug Labeling and Warnings

BRONCOLIN by is a Otc medication manufactured, distributed, or labeled by BRONCOLIN, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 7.5mg

Purpose

Cough Suppressant/Oral Anesthetic

Uses

temporarily relieves Cough due to minor and bronchial irritation occurring with a cold or inhaled irritants occasional minor irritation and sore throat

Warnings

Sore throat warning: If sore throat is severe persists for more than 2 days is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

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)

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe or irritation, pain, or redness lasts or worsens sore mouth does not improve in 7 days.

Keep out of reach of children

if pregnant or breast feeding ask a Health Professional before using

Directions

adults and children 6 years and older: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor children under 6 years: ask a doctor.

Inactive Ingredients

Citric Acid, Elderberry flower extract, Eucalyptus leaf extract, Eucalyptus oil leaf extract, Glucose, Honey, Mullein flower extract, Sugar, artificial flavor, contains FD&C Yellow No. 5 (tartrazine) as a color additive and FD&C Blue No.1

Package Label

INGREDIENTS AND APPEARANCE

BRONCOLIN  HONEY LEMON
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62583-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
EUCALYPTUS PIPERITA LEAF (UNII: 4GG3SCZ7GT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
HONEY (UNII: Y9H1V576FH)
VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	green (LIGHT GREEN)	Score	no score
Shape	ROUND (Lozenge)	Size	17mm
Flavor	HONEY (Honey and Eucalyptus)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62583-010-22	22 in 1 BAG; Type 0: Not a Combination Product	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2015

Labeler - BRONCOLIN, S.A. de C.V. (812946390)

Establishment
Name	Address	ID/FEI	Business Operations
BRONCOLIN, S.A. de C.V.		812946390	manufacture(62583-010)