FDA Label for Cvs Mucus Relief Dm And Overnight Cold And Flu
View Indications, Usage & Precautions
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS (MAXIMUM STRENGTH MUCUS RELIEF DM)
- USES (NIGHTTIME COLD AND FLU)
- IF PREGNANT OR BREAST FEEDING
- INACTIVE INGREDIENTS (OVERNIGHT COLD & FLU)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Cvs Mucus Relief Dm And Overnight Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Cvs. 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 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
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 irritants• the intensity of coughing• the impulse to 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
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
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 69842-696-12
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
• Controls Cough• Relieves chest congestion• Thins & loosens mucus• 4 hour dosing• Cough• Fever• Sore Throat• Runny Nose• Sneezing
For Ages 12+
*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
TRIPROLIDINE HCL • ANTIHISTAMINE
Night Time
Relief for Better Morning
Maximum Strength per 4-hour dose
For Ages 12+
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.
DO NOT TAKE ADULT DM MAXIMUM & NIGHTTIME COLD & FLU LIQUIDS AT THE SAME TIME. |
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.; |
See bottle for full labeling
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CVS Pharmacy, Inc.
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