FDA Label for Daytime Severe Congestion Relief And Nighttime Severe Cough And Congestion Relief Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 20 ML)
- ACTIVE INGREDIENTS FOR DAYTIME (IN EACH 20 ML)
- PURPOSE FOR NIGHTTIME
- PURPOSE FOR DAYTIME
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THESE PRODUCTS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Severe Congestion Relief And Nighttime Severe Cough And Congestion Relief Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.
Active Ingredients For Nighttime (In Each 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Active Ingredients For Daytime (In Each 20 Ml)
Acetaminophen 650 mg
Guaifeenesin 400 mg
Phenylephrine HCl 10 mg
Purpose For Nighttime
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Purpose For Daytime
Pain reliever
Expectorant
Nasal decongestant
Uses
Nighttime
- temporarily relieves
- headache
- nasal congestion
- 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
- temporarily relieves
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
Daytime
Warnings
NIGHTTIME and DAYTIME
Liver warning: This product contain 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
Nighttime
- with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on the skin
- 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
- for children under 12 years of age
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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.
Daytime
Ask A Doctor Before Use If You Have
Nighttime
- 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)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
- cough that occurs with too much phlegm (mucus)
Daytime
Ask A Doctor Or Pharmacist Before Use If You Are
Nighttime
- you are taking the blood thinning drug warfarin
- you are taking sedative or tranquilizers
- taking the blood thinning drug warfarin
Daytime
When Using These Products
Nighttime
- 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 vehicile or operating machinery
- do not use more than directed
Daytime
Stop Use And Ask A Doctor If
Nighttime
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- fever gets worse, or last more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be a signs of a serious condition
- 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 rash or headache that lasts. These could be signs of a serious condition.
Daytime
If Pregnant Or Breast-Feeding,
Nighttime and DayTime
ask a health professional before use.
Keep Out Of Reach Of Children.
Nighttime and DayTime
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 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
Nighttime
- 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
- keep dosing cup with product
- mL = mililiter
- 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
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- dose as follows or as directed by a doctor
- keep dosing cup with product
- mL = milliliter
- adults and children 12 years of age and older: 20 mL every 4 hours
- children under 12 years of age: do not use
Daytime
Other Information
Nighttime
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- each 20 mL contains: 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Daytime
Inactive Ingredients
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Nighttime and DayTime
Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
Principal Display Panel
NIGHTTIME
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 decongestant
MAXIMUM STRENGTH
Multi-Symptom
- Clears sinus congestion
- Relieves headache
- Relieves runny nose & sneezing
- Clear sinus congestion
- relieves headache
- Thins & loosens mucus
For Ages 12 & Over
DAYTIME
Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief*
ADULT Severe Congestion Relief
ACETAMINOPHEN - Pain reliever
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal decongestion
MAXIMUM STRENGTH
Multi-symptom
For Ages 12 & over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief & Night Time Congestion & Cough.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
Product Label
CVS HEALTH NightTime Severe Cough & Congestion Relief DayTime Adult Severe Congestion Relief
* Please review the disclaimer below.