BRONCOLIN HERBAL EXTRACTS AND HONEY- menthol lozenge 
BRONCOLIN, S.A. de C.V.

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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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

image description

BRONCOLIN  HERBAL EXTRACTS AND HONEY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62583-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (Amber) Scoreno score
ShapeROUND (Lozenge) Size17mm
FlavorHONEY (Herbs and Honey) Imprint Code BEE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62583-001-1616 in 1 BOX; Type 0: Not a Combination Product04/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/01/2014
Labeler - BRONCOLIN, S.A. de C.V. (812946390)
Establishment
NameAddressID/FEIBusiness Operations
BRONCOLIN, S.A. de C.V.812946390manufacture(62583-001)

Revised: 10/2022
Document Id: eb01be3e-e6ad-7793-e053-2995a90a44f7
Set id: 62b1d39a-b4d2-4e9d-ae41-7cfa1e661de1
Version: 3
Effective Time: 20221014
 
BRONCOLIN, S.A. de C.V.