BRONCOMAR MAXIMUM- dextromethorphan hbr, guaifenesin liquid 
Gadal Laboratories 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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Acvtive ingredients: (in 10 ml)              Purpose

Dextromethorphan HBr 30 mg ................... Cough Suppressant

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

Purpose

Cough Suppressant

Expectorant

Uses

Warnings

Do not exceed recommended dosage

Do not use

Ask the doctor before use if you have

Stop use and ask the doctor if

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 4 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

Children under 6 years of age                       Do not use

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C Red #40, glycerin, hydroxyethyl cellulose, natural strawberry flavor, water, sodium benzoate, sorbitol 70%, sucralose

BroncomarMax

BRONCOMAR  MAXIMUM
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-216
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 WHOLE (UNII: KIZ4X2EHYX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-216-061 in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2014
Labeler - Gadal Laboratories Inc (841305639)

Revised: 6/2014
Document Id: 9093948c-6ef7-48ce-b023-8d979a924cde
Set id: afbee087-62dc-4f5d-8155-2d6c1de320ed
Version: 1
Effective Time: 20140612
 
Gadal Laboratories Inc