Other
Drug Facts
Mucus Relief Dm And Overnight Cold And Flu
FDA Label NDC 0363-3998
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co for the product Mucus Relief Dm And Overnight Cold And Flu (NDC 0363-3998). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
▪ 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
Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\
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
- 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 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
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.
Value Pack Mucus Relief Dm And Overnight Cold And Flu (Ms Mucinex 01)
* Please review the disclaimer below.
