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NDC 62583-0001-16 BRONCOLIN 7.5 mg/1 Details

BRONCOLIN 7.5 mg/1

BRONCOLIN is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by BRONCOLIN, S.A. de C.V.. The primary component is MENTHOL.

Product Information

NDC	62583-0001
Product ID	62583-001_eb01be3e-e6ad-7793-e053-2995a90a44f7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BRONCOLIN
Proprietary Name Suffix	Herbal extracts and Honey
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	7.5
Active Ingredient Units	mg/1
Substance Name	MENTHOL
Labeler Name	BRONCOLIN, S.A. de C.V.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M012
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62583-0001-16 (62583000116)

Pricing Information	N/A
NDC Package Code	62583-001-16
Billing NDC	62583000116
Package	16 LOZENGE in 1 BOX (62583-001-16)
Marketing Start Date	2014-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62b1d39a-b4d2-4e9d-ae41-7cfa1e661de1 Details

Active Ingredient

Menthol 7.5mg

Purpose

Cough Suppressant/Oral Anesthetic

Uses

temporarily relieves •cough due to minor and bronchial 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 over: 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, Eucalyptus leaf, Eucalyptus oil, Glucose, Honey, Mullein flower, Propolis, Sugar

Package Label

INGREDIENTS AND APPEARANCE

BRONCOLIN HERBAL EXTRACTS AND HONEY

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62583-001
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
EUCALYPTUS PIPERITA LEAF (UNII: 4GG3SCZ7GT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
DEXTROSE (UNII: IY9XDZ35W2)
HONEY (UNII: Y9H1V576FH)
VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow (Amber)	Score	no score
Shape	ROUND (Lozenge)	Size	17mm
Flavor	HONEY (Herbs and Honey)	Imprint Code	BEE
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62583-001-16	16 in 1 BOX; Type 0: Not a Combination Product	04/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M012	04/01/2014

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

Name	Address	ID/FEI	Business Operations
Establishment
BRONCOLIN, S.A. de C.V.		812946390	manufacture(62583-001)

Revised: 10/2022

Document Id: eb01be3e-e6ad-7793-e053-2995a90a44f7

Set id: 62b1d39a-b4d2-4e9d-ae41-7cfa1e661de1

Version: 3

Effective Time: 20221014