OTC Medication Information: First Aid Direct Cough Relief DM

FIRST AID DIRECT COUGH RELIEF DM- guaifenesin and dextromethorphan hydrobromide 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.

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)

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pouch
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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

box
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
SODIUM CITRATE
SUCRALOSE
PROPYLPARABEN
METHYLPARABEN
WATER
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42961-121-02 6 DOSE PACK in 1 BOX contains a DOSE PACK (42961-121-01)
1 NDC:42961-121-01 10 mL in 1 DOSE PACK This package is contained within the BOX (42961-121-02)
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 Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture (42961-121)

Revised: 08/2022 Cintas Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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