MAXIMUM STRENGTH TUSSNEX FM DM MAX- dextromethorphan hbr, guaifenesin liquid 
Guardian Drug Company

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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Tussnex FM DM Max

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses

Warnings

Do not use

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronuc bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

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

Other information

Inactive ingredients

citric acid anhydrous, D&C red 33, dextrose, FD&C red 40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

PDP

compare to active ingredients in Mucinex®Fast-MaxTMDM Max

Maximum strength

Tussnex FM DM Max

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Multi-symptom

Relieves chest congestion

Thins and loosens mucus

Soothes cough

Dosing lasts 4 hours

For ages 12 & over

SN

MAXIMUM STRENGTH TUSSNEX FM DM MAX 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE (UNII: IY9XDZ35W2)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-628-58177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - Guardian Drug Company (119210276)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(53041-628)

Revised: 1/2022
Document Id: 5f24ed36-1675-43dd-9192-470eb8a85ec7
Set id: 0bae53e3-9661-4bc6-9fcc-da7fa131b034
Version: 3
Effective Time: 20220113
 
Guardian Drug Company