BIODESP DM NF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Advanced Generic Corporation

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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Drug Facts

Active Ingredients (in each 5mL)                              Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 100 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings:

Do no exceed recommended dosage

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask a doctor before use if you have

Stop use and ask a doctor if

Ask a doctor before use if you are taking sedatives or tranquilizers

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

If pregnant or breast-feeding, ask a doctor before use

Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.

AgeDose
Adults and children 12 years of age and over2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor

Inactive ingredients: citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose.

Questions or comments? 1-305-403-3788

BiodespDMNF

BIODESP  DM NF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-263
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-263-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 01e61e17-30cb-4c85-a365-b1d68514c06f
Set id: 82528dba-e3e7-416a-935d-7b6324a83f5a
Version: 5
Effective Time: 20201223
 
Advanced Generic Corporation