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

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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 DrugM01205/01/2012
Labeler - Guardian Drug Company (119210276)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(53041-628)

Revised: 12/2024
Document Id: e39a2556-4a5b-4306-b2d1-b93b75d39b06
Set id: 0bae53e3-9661-4bc6-9fcc-da7fa131b034
Version: 4
Effective Time: 20241219
 
Guardian Drug Company