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Cvs Maximum Strength Severe Congestion And Cough
FDA Label NDC 69842-967
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Maximum Strength Severe Congestion And Cough (NDC 69842-967). 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, keep out of reach of children, directions, other information, 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 Severe Congestion & Cough | Purposes |
|---|---|
Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg Phenylephrine HCl 10 mg | Expectorant Nasal decongestant |
| Active ingredients (in each 20 mL) | Purposes |
|---|---|
| Overnight Cold & Flu Clear & Cool | |
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg | Antihistamine/cough suppressant Nasal decongestant |
Triprolidine HCl 2.5 mg | Antihistamine |
Uses
MAXIMUM STRENGTH SEVERE CONGESTION & COUGH
▪ 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 irritants▪ the intensity of coughing▪ nasal congestion due to a cold▪ temporarily helps you cough less
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
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ trouble urinating due to an enlarged prostate gland▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema▪ cough that occurs with too much phlegm (mucus)
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 of age and older: 20 mL in dosing cup provided 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 over: 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 6 mg▪ low sodium▪ store at room temperature▪ do not refrigerate▪ dosing cup provided▪ each 20 mL contains: sodium 10 mg▪ store at room temperature▪ do not refrigerate
Inactive Ingredients (Maximum Strength Mucus Relief Dm)
anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No.1, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Uses (Overnight Cold & Flu Clear & Cool
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ nasal congestion▪ 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
If Pregnant Or Breast Feeding
ask a health professional before use
Inactive Ingredients (Overnight Cold & Flu)
anhydrous citric acid, ascorbic acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose and xanthan gum
Questions Or Comments?
(1-866-467-2748)
Principal Display Panel - Kit Carton
VALUE PACK
NDC 69842-967-12
Compare to Mucinex® Fast Max® DM Maximum Strength Severe Congestion & Cough Clear & Cool™ Active Ingredients*
Maximum Strength
Severe Congestion & Cough
Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
Phenylephrine HCl • Nasal Decongestant
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
- Cough
- Fever
- Sore Throat
- Runny Nose
- Sneezing
- Nasal Congestion
Cooling Menthol Flavor
Naturally and Artificially Flavored
For Ages 12+
6 FL. OZ. (180 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough Clear & Cool™
Compare to Mucinex® Nightshift Cold & Flu Clear & Cool Active Ingredients**
Overnight Cold & Flu
Clear & Cool
Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Phenylephrine HCl • Nasal Decongestant
Triprolidine HCl • Antihistamine
Maximum Strength per 4-hour dose
Night Time Relief for a Better Morning
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 Clear & Cool.
DO NOT TAKE MAXIMUM STRENGTH SEVERE CONGESTION & COUGH & OVERNIGHT COLD & FLU CLEAR & COOL LIQUIDS AT THE SAME TIME.
Cvs Value Pack Maximum Strength Severe Congestion & Cough Overnight Cold And Flu Clear And Cool (Ms Mucinex 01)
* Please review the disclaimer below.
