FIRST AID DIRECT COUGH RELIEF DM- guaifenesin dextromethorphan hbr syrup

First Aid Direct Cough Relief DM by

Drug Labeling and Warnings

First Aid Direct Cough Relief DM by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each 5mL/1 teaspoon)

• Dextromethorphan HBr 10mg
• Guaifenesin 100 mg

Purposes

cough suppressant

expectorant

Uses

temporarily:

• relieves coughing due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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.

• adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours
• children 6-11 years, measure out and take only 1 teaspoon every 4 hours
• children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours
• children under 2 years, consult your doctor

Other information

• do not use if dispenser is torn, cut or opened
• store at room temperature
• avoid excessive heat and humidity

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)

Package Label Principal Display Panel Box

Cough Relief DM

COUGH SUPPRESSANT

EXPECTORANT

LIQUID COUGH FORMULA

• CONTROLS COUGHS
• LOOSENS and RELIEVES CHEST CONGESTIONS
• ALCOHOL-FREE
• NON DROWSY FORMULA

6-10mL Doses per Box

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT COUGH RELIEF DM 
guaifenesin dextromethorphan hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-121-02	6 in 1 BOX	05/13/2022
1	NDC: 42961-121-01	10 mL in 1 DOSE PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/13/2022

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42961-121)