Maximum Strength Mucus Relief Dm And Overnight Cold & Flu Value Pack

Maximum Strength Mucus Relief Dm And Overnight Cold & Flu Value Pack
SPL v3
SPL
SPL Set ID 6b79cb3b-9d9e-4ea5-b7a6-bbcd07471d2a
Route
ORAL
Published
Effective Date 2022-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Acetaminophen (650 mg) Triprolidine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum Glycerin Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-03-30

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 55105-1
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

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.
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 10 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
Other Information
  • each 20 mL contains: sodium 8 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
Questions Or Comments?

(1-866-467-2748)

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 sings 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 Centre right away at 1-800-222-1222

Uses (nighttime Cold and Flu)
  • 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
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)
Principal Display Panel Kit Carton

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.

Inactive Ingredients (overnight Cold & Flu)

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

Inactive Ingredients (maximum Strength Mucus Relief Dm)

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)
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

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.
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 10 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
Other Information (Other information)
  • each 20 mL contains: sodium 8 mg
  • low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided
Questions Or Comments? (Questions or comments?)

(1-866-467-2748)

Stop Use and Ask A Doctor If (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 sings of a serious condition.
If Pregnant Or Breast Feeding (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 Centre right away at 1-800-222-1222

Uses (nighttime Cold and Flu) (Uses (Nighttime Cold and Flu))
  • 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
Ask A Doctor Before Use If You Have (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)
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

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.

Inactive Ingredients (overnight Cold & Flu) (Inactive ingredients (Overnight Cold & Flu))

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

Inactive Ingredients (maximum Strength Mucus Relief Dm) (Inactive ingredients (Maximum strength mucus relief DM))

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


Advanced Ingredient Data


Raw Label Data

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