CVS Health™ Day and Night Twin Pack Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Nighttime Cold and Flu Relief Single Serve Cups

Drug Labeling and Warnings

Drug Details [pdf]

CVS HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF DAY AND NIGHT TWIN PACK- acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl ,acetaminophen,dextromethorphan hbr,doxylamine succinate 
CVS Pharmacy,Inc.

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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CVS Health Day and Night Twin Pack Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Nighttime Cold and Flu Relief Single Serve Cups

Drug Facts Daytime Cold & Flu Relief

Active ingredients (in each single serve cup)Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Phenylephrine HCl 10 mg

Nasal decongestant

Drug Facts Nighttime Cold & Flu Relief

Active ingredients (in each single serve cup)Purposes

Acetaminophen 650 mg

Pain reliever/Fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Uses

Daytime

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  •   Nighttime

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

Warnings

Liver warning:

Daytime

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
  •   Nighttime

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning:

Daytime

If sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  •   Nighttime

If sore throat is severe, lasts for more than 2 days, is accompanied with or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  •   Daytime
  •   Nighttime
  • with any other products 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  •   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.
  • 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
  •   Nighttime
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to 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
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

Daytime

taking the blood thinning drug warfarin.

  •   Nighttime
  •   taking sedatives or tranquilizers
  •   taking the blood thinning drug warfarin

When using this product, do not use more than directed.

  •   Daytime
  •   Nighttime
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

  •   Daytime
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults)
  • 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

  • pain 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.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

Daytime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nighttime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Daytime

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12yrs & over

one cup every 4 hrs

children under 12yrs

do not use

  • place single–serve cup in K-cup®compatible brewer†
  • use a minimum of 8 oz of water
  • when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping.
  • DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in the K-Cup® compatible brewer and could result in hot water burns.
  • Flush brewer after use
  •   Nighttime
  •   take only as directed - see Overdose warning
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12yrs & over

one cup every 6 hrs

children under 12yrs

do not use

  • place single-serve cup in K-Cup®compatible brewer†
  • use a minimum of 8 oz of water
  • when finished, the single serve cups are hot and may drip.
  •   Tilt the cup during removal to avoid dripping.
  •   DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in the K-Cup® compatible brewer and could result in hot water burns
  • DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in the K-Cup® compatible brewer and could result in hot water burns
  • Flush brewer after use

Other information

Daytime

  • store at room temperature
  •   Nighttime

Inactive ingredients

Daytime

citric acid, FD&C Red No. 40, flavors, isomalt , silica, sucralose

Nighttime

citric acid, FD&C Yellow No.6, flavors, isomalt, silica , sucralose

Questions or comments?

Daytime

1-866-467-2748

Nighttime

1-866-467-2748

PRINCIPAL DISPLAY PANEL

DAY & NIGHT TWIN PACK

CVS Health

NDC: 59779-690-08

Compare to the active ingredients in Vicks® DayQuil®Cold & Flu*

Non-Drowsy

Daytime

Cold & Flu Relief

Single serve

Cups

COMPATIBLE WITH ALL KEURIG® K- CUP MACHINES†

ACETAMINOPHEN

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

  • Headache, fever, sore throat
  • Minor aches & pains
  • Nasal congestion
  • Cough

Berry infused with Menthol & Green Tea Flavors

Naturally and Artificially Flavored

Alcohol free

4 DAYTIME CUPS

Compare to the active ingredients in Vicks® NyQuil®Cold & Flu*

Nighttime

Cold & Flu Relief
Single Serve

Cups

COMPATIBLE WITH ALL KEURIG® K- CUP MACHINES†

ACETAMINOPHEN

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant
DOXYLAMINE SUCCINATE

Antihistamine

Relieves:

  • Headache, fever, sore throat
  • Minor aches and pains
  • Sneezing, runny Nose
  • Cough
  •   Honey Lemon Infused Chamomile & White Tea Flavors
  •   Naturally and Artificially Flavored
  •   Alcohol free

4 NIGHTTIME CUPS

8 TOTAL SINGLE SERVE CUPS

Our single serve cold and flu relief cups are a warm and easy way to feel better fast. Just use our cups as you would any other single serve cup in your Keurig® machine for a great- tasting, flu-relieving drink anytime .Whether you need a non- drowsy way to get through a long day ahead ,or you are finally tucking yourself into bed at night, take a moment and toast to relief.

*This product is not manufactured or distributed by Procter and Gamble, distributor of Vicks® DayQuil ®Cold & Flu and Vicks® NyQuil® Cold &Flu.

†COMPATIBLE WITH KEURIG® K- CUP® BREWERS & 2.0 BREWING SYSTEMS.

THIS PRODUCT IS NOT AFFILIATED WITH KEURIG, INC.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive ,Woonsocket, RI 02895

©2016 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A with domestic and foreign ingredients

V-12431

CVS Quality

Money Back Guarantee

PATENT PENDING

TAMPER EVIDENT: DO NOT USE IF SEALED CUP IS TORN AND BROKEN.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 4 DOSES IN ANY 24 –HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.

CVS Health Combo
CVS HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF  DAY AND NIGHT TWIN PACK
acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl ,acetaminophen,dextromethorphan hbr,doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-690
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-690-081 in 1 KIT; Type 1: Convenience Kit of Co-Package08/15/201607/22/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 CUP
Part 24 CUP
Part 1 of 2
CVS HEALTH DAYTIME COLD AND FLU RELIEF  DAYTIME
acetaminophen ,dextromethorphan hydrobromide and phenylephrine hcl powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
11 in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/201607/22/2019
Part 2 of 2
VS HEALTH NIGHTTIME COLD AND FLU RELIEF  NIGHTTIME
acetaminophen,dextromethorphan hbr,doxylamine succinate powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ISOMALT (UNII: S870P55O2W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
11 in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/201607/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/201607/22/2019
Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 7/2019
 

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