Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Sinus Relief Congestion And Cough
FDA Label NDC 69842-461
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 Pharmacy for the product Sinus Relief Congestion And Cough (NDC 69842-461). 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 active ingredients (in each 20 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain Reliever
Antihistamine / cough suppressant
Nasal decongestant
Uses
- temporarily relieves
- nasal congestion
- headache
- minor aches and pains
- cough
- sinus congestion and pressure
- runny nose and sneezing
- temporarily promotes nasal and/or sinus drainage
- controls cough to help you get to sleep
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on the skin
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
- you are taking the blood thinning drug warfain
- you are taking sedatives or tranquilizers
When Using This Product,
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warnings: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- dose as follows or as directed by a doctor
- adults and children 12 years and older:
- 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Other Information
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sodium citrate, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX Night Time Congestion & Cough*
Nighttime
Severe Cough & Congestion Relief
ACETAMINOPHEN - Pain reliever
DIPHENHYDRAMINE HCI / Antihistamine / Cough suppressant
PHENYLEPHRINE HCI - Nasal decognesant
MAXIMUM STRENGTH
Multi-Symptom
- Clears sinus congestion
- Relieves headache
- relieves runny nose & sneezing
For Ages 12 & Over
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Night Time Congestion & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
Package Label
CVS HEALTH Nighttime Severe Cough & Congestion Relief
* Please review the disclaimer below.
