DRUG FACTS

DAYTIME NIGHTTIME COLD/FLU- acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci   
CVS Pharmacy

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.

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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

NIGHTTIME

Warnings

DAYTIME and NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

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

  • 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

Other information

DAYTIME

NIGHTTIME

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

Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine 10 mg, Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg

CVS HEALTH Daytime and Nighttime Severe Cold & Flu

DAYTIME NIGHTTIME COLD/FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-686
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-686-16 1 in 1 KIT; Type 0: Not a Combination Product 07/31/2016
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 245 mL
Part 2 1 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 Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-691-08 245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/31/2016
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Product Information
Item Code (Source) NDC:59779-693
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-693-08 245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/31/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/31/2016
Labeler - CVS Pharmacy (062312574)

Revised: 10/2019
Document Id: a512be03-c5ca-44ac-99e4-ceed0b40605b
Set id: 9509fec8-8056-435b-8687-f01648af49a1
Version: 4
Effective Time: 20191025
 
CVS Pharmacy