FDA.reportPublic FDA data

Mucus Relief DM and Overnight Cold and Flu

Manufacturer
WALGREENS CO
Effective date
2022-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:23

Label at a glance#

ProductMucus Relief DM and Overnight Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, Acetaminophen, TRIPROLIDINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

MAXIMUM STRENGTH MUCUS RELIEF DM • 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 imitants • the intensity of coughing • the impulse to cough to help you get to sleep

Dosage and administration

• 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Maximum Strength Mucus Relief DM Max		Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Active ingredients (in each 20 mL)Purposes
Nighttime Cold & Flu

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Triprolidine HCl 2.5 mg

Antihistamine

Uses

INDICATIONS & USAGE SECTION

MAXIMUM STRENGTH MUCUS RELIEF DM

  • 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 imitants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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 that directed

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition.
If pregnancy or breast-feeding, ask a health professional before use

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison control Centre right away at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients (Maximum strength mucus relief DM)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Uses (Nighttime Cold and Flu)

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222.

Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warnings
  • do not take more than 4 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 older: 20 ml in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Other Information

OTHER SAFETY INFORMATION

  • each 20 mL contains: sodium 10 mg
  • low sodium
  • store at room temperature
  • do not refrigerate

Inactive ingredients (Overnight Cold & Flu)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

(1-866-467-2748)

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE PACK

NDC 0363-3998-12

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

Mucus Relief DM

Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
MAXIMUM STRENGTH

MULTI-SYMPTOM

  • Relieves chest congestion & cough
  • Thins & loosens mucus
  • 4 hour dosing
  • 12 years & older

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

Compare to Mucinex® Nightshift Cold & Flu Active Ingredients**

Nighttime Cold & Flu

ACETAMINOPHEN • PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBR • COUGH SUPPRESSANT

TRIPROLIDINE HCL • ANTIHISTAMINE

MULTI-SYMPTOM

Maximum Strength per 4-hour dose

  • Nighttime relief for a better morning
  • Relieves cough, fever, sore throat, runny nose & sneezing
  • Maximum Strength per 4-hour dose
  • 12 years & older

2 – 6 FL OZ (180 mL) BOTTLES / TOTAL 12 FL OZ (360 mL)

††These product is not manufactured or distributed by Reckitt Benckister Health, distributor of Maximum Strength Mucinex® Fast Max© DM Max & Mucinex© Nightshift Cold & Flu.

TAMPER EVIDENT: DO NOT TAKE MAXIMUM STRENGTH MUCUS RELIEF DM & OVERNIGHT COLD & FLU LIQUIDS AT THE SAME TIME.

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

See bottle for full labeling.

Walgreens DM Max and Nighttime Cold and Flu Combo Pack
Walgreens DM Max and Nighttime Cold and Flu Combo Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287760{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK3
22877601 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSN3
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN3
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN3
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD3
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
22877601 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSY3
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY3
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY3
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY3
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3998-122024-01-30C16284748780-11030e364-fb3a-111a-e063-dadaa90a10e2Maximum Strength Mucus Relief DM and Overnight Cold & Flu Value Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3998-12Mucus Relief DM and Overnight Cold and Flu1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3998MUCUS RELIEF DM AND OVERNIGHT COLD AND FLU (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL) KIT [WALGREENS CO]3Legacy NDC, 1 package rows20220106_6b79cb3b-9d9e-4ea5-b7a6-bbcd07471d2a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-39980363-3998-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C Blue No. 1H3R47K3TBDIACT
FD&C Red No. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
propylene glycol6DC9Q167V3IACT
propyl gallate8D4SNN7V92IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
xanthan gumTTV12P4NEEIACT
Acetaminophen362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
anhydrous citric acidXF417D3PSLIACT
edetate disodium7FLD91C86KIACT
FD&C Blue No. 1H3R47K3TBDIACT
FD&C Red No. 40WZB9127XOAIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d203cb84-8ab2-433a-b670-5b264055349b6b79cb3b-9d9e-4ea5-b7a6-bbcd07471d2a2022-01-05WarningsExact identifier
spl id: d203cb84-8ab2-433a-b670-5b264055349b
spl set id: 6b79cb3b-9d9e-4ea5-b7a6-bbcd07471d2a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.