MUCUS RELIEF DM MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin liquid

Mucus Relief DM by

Drug Labeling and Warnings

Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Cough suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of botherosme 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 (1800-222-1222) right away.

Directions

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

Other information

• each 20 mL contains: sodium 20 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, disodium EDTA FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

*Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® DM Max

maximum strength mucus Relief dm max

Dextromethorphan HBr

Guaifenesin

relieves

• cough
• Chest congestion & mucus
• 4-hour dosing

for ages 12 years & over

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Package Label

ReadyinCase Mucus Relief DM Max

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0505
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)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0505-6	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2016	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/30/2016	12/30/2021

Labeler - P & L Development, LLC (101896231)