BRONCOMAR- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl 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

Acetaminophen 200 mg ............................. Analgesic

Dextromethorphan HBr 13.33 mg ................... Cough Suppressant

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

Phenylephrine HCl 5 mg ............................. Decongestant

Purpose

Analgesic

Cough Suppressant

Expectorant

Decongestant

Uses

Warnings

Do not exceed recommended dosage

Liver warning: This product contains Acetaminophen. Sever liver damage may occur if

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 6 hours

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

Children under 6 years of age                       Do not use

Inactive ingredients

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

BroncomarEx

BRONCOMAR 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-215
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 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)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-215-061 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: c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae
Set id: 058cdaf3-ed98-44b2-9ecc-fd810dcac12e
Version: 1
Effective Time: 20140623
 
Gadal Laboratories Inc