FIRST AID DIRECT COUGH RELIEF DM- guaifenesin dextromethorphan hbr syrup 
Cintas 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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First Aid Direct Cough Relief

Active ingredients (each 5mL/1 teaspoon)

Purposes

cough suppressant

expectorant

Uses

temporarily:

Warnings

Do not use

this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Stop use and ask doctor if

  • cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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

do not take more than 6 doses in 24 hours, or as directed by a doctor.

Other information

Inactive ingredients

citric acid, FD&C red 40, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

Questions?

1-800-327-2704

Package Label Principal Display Panel Single Dose Pack

BEND HERE 

AND TEAR

Cough Relief DM

COUGH SUPPRESSANT EXPECTORANT

1/3 FL OZ (10 mL)

(2 Teaspoons)

pouch

pouch

Package Label Principal Display Panel Box

Cough Relief DM

COUGH SUPPRESSANT

EXPECTORANT

LIQUID COUGH FORMULA

6-10mL Doses per Box

box

FIRST AID DIRECT COUGH RELIEF DM 
guaifenesin dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42961-121-026 in 1 BOX05/13/2022
1NDC:42961-121-0110 mL in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/13/2022
Labeler - Cintas Corporation (056481716)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(42961-121)

Revised: 8/2022
Document Id: 87824a21-c2c7-4af6-b55a-957676b01f06
Set id: d214b3e2-a626-42e9-a587-727b9017d62e
Version: 2
Effective Time: 20220810
 
Cintas Corporation