BRONCOMAR MAXIMUN COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid 
Dannso Corp./d.b.a. Essential Products

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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Broncomar Maximum Cought Relief

Active Ingredients:(in each 10 ml.)Purpose

Dextromethorphan Hydrobromide 30 mg ....................

Cough Suppressant

Guaifenesin 200 mg.......................................................

Expectorant

Uses:

Warnings

Do not exceed recommended dosage


Do not use


Stop use and ask a doctor

Ask doctor before use if you have

If pregnant or breast-feeding ask a health professional before use.


Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


AGE
DOSE
Adults and Children 12 years and over
10 ml (2 tsps) every 6 hours
Children 6 to under 12 years of age
5 ml (1 tsp) every 6 hours
Children under 6 years of age
Do not  use



Other Information:

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Glycerin, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

Broncomar Maximun Cough Label

BRONCOMAR  MAXIMUN COUGH RELIEF
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70242-103-061 in 1 CARTON01/01/2015
1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2001
Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC078572520MANUFACTURE(70242-103)

Revised: 1/2016
Document Id: 79da1c58-44ee-43f6-a452-7b9047e5d278
Set id: 3a7986cd-b16e-4201-95b1-f53b9a6c2529
Version: 4
Effective Time: 20160101
 
Dannso Corp./d.b.a. Essential Products