FDA Label for Mucus Relief Dm And Overnight Cold And Flu

View Indications, Usage & Precautions

Mucus Relief Dm And Overnight Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens Co. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

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

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Antihistamine/cough suppressant

Triprolidine HCl 2.5 mg

Nasal decongestant


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
      • ▪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



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.
  • 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

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)

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.

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

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



  • •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
    • 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



  • •each 20 mL contains: sodium 8 mg
  • •low sodium
  • •store at room temperature
  • •do not refrigerate
  • •dosing cup provided
    • each 20 mL contains: sodium 10 mg
    • ▪low sodium
    • ▪store at room temperature
    • ▪do not refrigerate

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


If Pregnant Or Breast Feeding



Ask a health professional before use


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


Questions Or Comments?



(1-866-467-2748)


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

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4 Hour Dosing
  • For Ages 12+

    6 FL. OZ. (180 mL)

    *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**

    Overnight Cold & Flu

    Acetaminophen • Pain Reliever/Fever Reducer
    Dextromethorphan HBr • Cough Suppressant
    Phenylephrine HCl • Nasal Decongestant

    Triprolidine HCl • Antihistamine

    Night Time Relief for a Better Morning

    Maximum Strength per 4-hour dose

    • Cough
      Fever & Sore Throat
    • Fever
    • Sore Throat
    • Runny Nose
    • Sneezing
    • For Ages 12+

      6 FL OZ (180 mL)

      **This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu.

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


* Please review the disclaimer below.