CVS Health Nighttime COLD and FLU Relief Single Serve Cups 8 Count

Drug Labeling and Warnings

Drug Details [pdf]

CVS HEALTH NIGHTTIME COLD AND FLU RELIEF SINGLE SERVE CUPS COLD AND FLU NIGHTTIME RELIEF- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate powder, for solution 
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 Nighttime COLD and FLU
Relief Single Serve Cups 8 Count

Drug Facts

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

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning:

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

Sore throat warning:

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

Do not use

  • 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 drugs. 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

  • 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

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

When using this product

  • 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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • 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.

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

  • 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 8oz 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

Other information

  • store at room temperature

Inactive ingredients

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

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

CVS Health

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

NDC: 59779-694-08

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:
  •   Honey Lemon Infused with Chamomile & White Tea Flavors
  • Headache, fever , sore throat
  • Minor aches & pains
  • Sneezing, runny nose
  • Cough
  •   Honey Lemon Infused with Chamomile & White Tea Flavors

Alcohol free

Actual Product

Size on Side Panel

8 SINGLE SERVE CUPS

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

Nighttime Cold & Flu Relief Single Serve Cups

CVS Health Nighttime Cold and Flu Relief Single Serve 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. When you’ve gotten through a long day, and are looking forward to a peaceful night, take a moment for yourself and toast to relief.

PATENT PENDING

COMPATIBLE WITH ALL KEURIG® K-CUP MACHINES†

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

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

CVS Quality

Money back Guarantee

PATENT PENDING

‡COMPATIBLE WITH KEURIG® K-CUP® BREWERS & 2.0 BREWING SYSTEMS THIS PRODUCT IS NOT AFFILIATED WITH KEURIG,INC.

CVS Health Nighttime Cold and Flu Relief Single Serve Cups
CVS HEALTH NIGHTTIME COLD AND FLU RELIEF SINGLE SERVE CUPS  COLD AND FLU NIGHTTIME RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-694
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg  in 6 g
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide30 mg  in 6 g
Doxylamine succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine succinate12.5 mg  in 6 g
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
1NDC: 59779-694-088 in 1 CARTON08/15/201607/22/2019
16 g in 1 CUP, UNIT-DOSE; 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
Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 7/2019
 
CVS Pharmacy,Inc.