MUCUS RELIEF DM HONEY AND BERRY FLAVOR- dextromethorphan hydrobromide and guaifenesin solution

Mucus Relief DM Honey and Berry Flavor by

Drug Labeling and Warnings

Mucus Relief DM Honey and Berry Flavor by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. 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

• ▪ 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 headache that lasts. 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 1-800-222-1222.

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
• ▪ adults and children 12 years of age and over: 20 mL in dosing cup provided 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

Inactive ingredients

citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

*Compare to the active ingredient in Maximum Strength Mucinex® Fast Max® DM Max Honey & Berry Flavor

NDC: 68163-605-06

DRx Choice

maximum Strength

Mucus

relief DM

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

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

Honey& Berry Flavor

Naturally and Artificially Flavored

For Ages 12+

6 FL OZ (180mL)

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court

East Brunswick,

NJ 08816

*This product is not manufactured or distributed by RB Health (US) the distributor of Maximum Strength Mucinex® Fast-Max® DM Max Honey & Berry Flavor

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM HONEY AND BERRY FLAVOR 
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-605
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)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-605-06	180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	04/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/21/2023

Labeler - RARITAN PHARMACEUTICALS INC (127602287)