Active Ingredients In Daytime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu Kit
FDA Label NDC 69842-906
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 Mucus Relief Severe Cold And Nighttime Cold And Flu (NDC 69842-906). 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/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purpose For Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
DAYTIME
- temporarily relieves these common cold and flu symptoms
- headache
- nasal congestion
- sore throat
- cough
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily reduces fever
- temporarily relieves these common cold and flu symptoms
- cough
- headache
- minor aches and pains
- sore throat
- nasal congestion
- runny nose and sneezing
- controls cough to help you get to sleep
- temporarily reduces fever
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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
- diabetes
- high blood pressure
- 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
- diabetes
- high blood pressure
- heart disease
- glaucoma
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or 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 (Daytime and NightTime) 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 (Daytime and Nighttime) 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
- store between 20-25°C (68-77°F)
- avoid excessive heat
- swallow whole, do not crush, chew, or dissolve
Inactive Ingredients
DAYTIME
FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, 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
DAY & NIGHT COMBO PACK
Compare to the active ingredients in Maximum Strength Mucinex® FAST-Max® Day Severe Cold Liquid Gels and Night Cold & Flu Liquid Gels†
DAYTIME
MAXIMUM STRENGTH
Daytime Severe Cold
Acetaminophen 325 mg Pain Reliever ; Fever Reducer
Dextromethorphan HBr 10 mg Cough Suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCL - 5 mg Nasal Decongestant
MULTI-SYMPTOM
- Relieves cough
- Thins & loosens mucus
- Relieves nasal & chest congestion
- Relieves aches, fever & sore throat
- Relieves cough
- Relieves runny nose & sneezing
- Relieves nasal congestion
- Relieves aches, fever & sore throat
FOR AGES 12+
SOFTGELS**
(Liqui-filled capsules)
NIGHTTIME
MAXIMUM STRENGTH
Nighttime Cold & Flu
Acetaminophen 325 mg Pain reliever, Fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
Phenylephrine HCL 5 mg Nasal decongestant
MULTI-SYMPTOM
FOR AGES 12+
SOFTGELS**
(*Liqui-Filled Capsules)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Day Severe Cold and Maximum Strength Mucinex® Fast-Max® Night Cold & Flu 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 Severe Cold, Maximum Strength Nighttime Severe Cold
* Please review the disclaimer below.
