Active Ingredients In Daytime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Daytime Nighttime Sinus Relief Kit
FDA Label NDC 69842-908
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 Daytime Nighttime Sinus Relief (NDC 69842-908). 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 daytime (in each softgel), active ingredients in nighttime (in each softgel), purpose for daytime, purpose for nighttime, uses, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients In Nighttime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCI 5 mg
Purpose For Daytime
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant
Purpose For Nighttime
Pain reliever
Cough suppressant
Antihistamine
Nasal decongestant
Uses
DAYTIME
- temporarily relieves
- nasal congestion
- headache
- cough
- sinus congestion and pressure
- minor aches and pains
- 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 coughs more productive
- temporarily relieves
- nasal congestion
- cough
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- temporarily promotes nasal and/or sinus drainage
NIGHTTIME
Warnings
DAYTIME and NIGHTTIME
Liver warning: These products 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
DAYTIME and NIGHTTIME
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
Ask A Doctor Before Use If You Have
DAYTIME
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- breathing problem s 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)
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
taking the blood thinning drug warfarin
NIGHTTIME
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product,
DAYTIME
do not use more than directed
NIGHTTIME
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
DAYTIME and NIGHTTIME
- 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 coukld be signs of a serious condition.
If Pregnant Or Breast-Feeding,
DAYTIME and NIGHTTIME
ask a health professional before use.
Keep Out Of Reach Of Children.
DAYTIME and NIGHTTIME
Overdose warning: Taking more than the recommended dose can 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
DAYTIME
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels in any 24-hour period
- adults and children 12 years of age and older: take 2 softgels every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels in any 24-hour period
- adults and children 12 years of age and older: take 2 softgels every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
NIGHTTIME
Other Information
DAYTIME and NIGHTTIME
- swallow whole; do not crush, chew, or dissolve
- store between 15-30°C (59-86F)
- avoid excessive heat
Inactive Ingredients
DAYTIME
FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
NIGHTTIME
D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
DAYTIME and NIGHTTIME
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night Liquid Gel*
MAXIMUM STRENGTH
DAYTIME
Sinus Relief
ACETAMINOPHEN - 325 mg Pain reliever
DEXTROMETHORPHAN HBr - 10 mg Cough suppressant
GUAIFENESIN - 200 mg Expectorant
PHENYLEPHRINE HCL - 5 mg Nasal decongestant
- Relieves sinus pressure, headache & congestion
- Controls cough
- thins & loosens mucus
- Relieves nasal congestion, sinus pressure & pain
- Controls cough
- Controls runny nose and sneezing
FOR AGES 12 YEARS & OLDER
Alcohol Free
SOFTGELS**
MAXIMUM STRENGTH
NIGHTTIME
Sinus Relief
ACETAMINOPHEN - 325 mg Pain reliever
DEXTROMETHORPHAN HBr - 10 mg Cough suppressant
DOXYLAMINE SUCCINATE - 6.25 mg Antihistamine
PHENYLEPHRINE HCL - 5 mg Nasal decongestant
FOR AGES 12 YEARS & OLDER
Alcohol Free
SOFTGELS*
(**Liquid-filled capsules)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.Liquid Gels.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Product Label
CVS HEALTH Maximum Strength Daytime Nighttime Sinus Relief
* Please review the disclaimer below.
