MAXIMUM STRENGTH MUCUS RELIEF DM- dextromethorphan hydrobromide and guaifenesin solution

Maximum Strength Mucus Relief DM by

Drug Labeling and Warnings

Maximum Strength Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Uses

• ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• ▪ temporarily relieves:
  • ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • ▪ the intensity of coughing
  • ▪ the impulse to cough to help you get to sleep

Warnings

Do not use

• ▪ for children under 12 years of age
• ▪ 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic 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 at 1-800-222-2222.

Directions

• ▪ do not take more than 6 doses in any 24-hour period
• ▪ measure only with dosing cup provided
• ▪ do not use dosing cup with other products
• ▪ dose as follows or as directed by a doctor
• ▪ mL = milliliter
• ▪ Adults and children 12 years and older: 20 mL every 4 hours
• ▪ Children under 12 years of age: Do not use

Other information

• ▪ each 20 mL contains: sodium 8 mg
• ▪ store at room temperature
• ▪ do not refrigerate
• ▪ dosing cup provided
• ▪ low sodium

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue#1,FD&C red #40, flavors, potassium citrate , propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose ,xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

LEADER

NDC: 70000-0129-1

Maximum Strength

Mucus Relief DM

Dextromethorphan HBr ǀ Guaifenesin
Cough Suppressant ǀ Expectorant

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST MAX® DM MAX active ingredients*

100% Money back Guarantee

For Ages 12+

• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens Mucus
• 4 Hour Dosing
• Maximum Strength Formula

6 FL OZ (180 mL)

Tamper evident: do not use if printed seal under cap is broken or missing.

©2017 Cardinal Health, All Rights Reserved , CARDINAL HEALTH ,the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™ since 1979

*This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademarks

Maximum Strength Mucinex® Fast -Max® DM Max.

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCUS RELIEF DM 
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0129
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	dextromethorphan hydrobromide	20 mg  in 20 mL
guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ)	guaifenesin	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
edetate disodium (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C red No. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
propylene glycol (UNII: 6DC9Q167V3)
propyl gallate (UNII: 8D4SNN7V92)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
xanthan gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0129-1	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/06/2017

Labeler - CARDINAL HEALTH (097537435)