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DayTime NightTime Cold/Flu by CVS Pharmacy

Dosage form: kit
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL; ACETAMINOPHEN 650mg in 30mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: CVS Pharmacy
NDC Code: 59779-686

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredients in Daytime (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Active ingredients in Nighttime (in each 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg 

Phenylephrine HCI 10 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Antihistamine / Cough suppressant

Nasal decongestant

Uses DAYTIME
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • sore throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

NIGHTTIME

  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • sore throat
    • runny nose
    • sneezing
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • itchy of the nose or throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

  • 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, ot 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.

NIGHTTIME 

  • to make a child sleepy
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product 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.

Ask a doctor before use if you have

DAYTIME

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

NIGHTTIME

  • liver disease
  • glaucoma
  • high blood pressure
  • heart disease
  • diabetes
  • thyroid disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

DAYTIME

taking the blood thinning drug warfarin

NIGHTTIME

  • the blood thinning drug warfarin
  • sedative or tranquilizers

When using this product,

DAYTIME
do not exceed recommended dosage.

NIGHTTIME

  • do not exceed recommended dosage
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur
  • excitability may occur, especially in children 

Stop use and ask a doctor if

DAYTIME 

  • nervousness, dizziness or sleeplessness occur
  • pain, cough,or nasal congestion 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.

NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with 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.

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 and NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses (180 mL) in any 24-hour peroid 
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  •  adults and children 12 years and over:
  • children under 12 years: do not use

Other information DAYTIME
  • each 30 mL Contains: sodium 16 mg
  • store between 20-25ºC (68-77º). Do not refrigerate

NIGHTTIME

  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

DAYTIME

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

NIGHTTIME

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

DAYTIME & NIGHTTIME

Compare to the active ingredients in Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough*

Daytime

Severe Cold & Flu

ACETAMINOPHEN

Pain reliever; fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

PHENYLEPHRINE HCI

Nasal decongestant

Relief of:

Nasal congestion; Cough; Fever; Body ache; Sore Throat; Headache

Berry Flavor

Alcohol content 10%

For Ages 12 & Over

Nighttime

Severe Cold & Flu

ACETAMINOPHEN

Pain reliever; Fever reducer

DIPHENHYDRAMINE HCI

Anthihistamine; Cough suppressant

PHENYLEPHRINE HCI

Nasal decongestant

Relief of:

Nasal congestion; Cough; Fever; Body ache; Sore throat; Headache

Dosing Cup Included

Berry Flavor

Alcohol content 10%

for Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by GSK Comsumer Healthcare, distributor of Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & 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® 1-800-SHOP CVS

Product Label

CVS HEALTH Daytime and Nighttime Severe Cold & Flu

DAYTIME NIGHTTIME COLD/FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-686
Packaging
#Item CodePackage Description
1NDC:59779-686-161 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 245 mL
Part 21 BOTTLE, PLASTIC 245 mL
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Item Code (Source)NDC:59779-691
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-691-08245 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/2016
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Product Information
Item Code (Source)NDC:59779-693
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-693-08245 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/2016
Labeler - CVS Pharmacy (062312574)

Revised: 01/2018
 
CVS Pharmacy

← See all DayTime NightTime Cold/Flu brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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