CVS Health Daytime Cold and Flu Relief Single Serve Cups

Drug Labeling and Warnings

Drug Details [pdf]

CVS HEALTH NON-DROWSY DAYTIME COLD AND FLU RELIEF SINGLE SERVE CUPS DAYTIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride 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 Daytime Cold and Flu Relief Single Serve Cups

Drug Facts

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

Uses

temporarily relieves common cold/flu symptoms:

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

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 with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• 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.

Ask a doctor before use if you have

• 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 as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

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

Stop use and ask a doctor if

• 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.

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 12 yrs & over:

  One cup every 4 hrs

• children under 12yrs:

  do not use

Other information

• store at room temperature

Inactive ingredients

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

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

CVS Health™

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

NDC# 59779-688-08

Non -Drowsy

Daytime

Cold & Flu Relief

Single Serve Cups

COMPATIBLE WITH ALL KEURIG® K- CUP MACHINES†

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

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

Actual Product Size on Side panel

8 SINGLE SERVE CUPS

CVS Health™ Daytime 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’re facing a long day ahead, take a moment for yourself and toast to relief.

CVS Health™

Non –Drowsy

Daytime

Cold & Flu Relief

Single Serve Cups

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr- Cough suppressant

Phenylephrine HCl – Nasal decongestant

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

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

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

PATENT PENDING

CVS Quality

Money back Guarantee

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

CVS HEALTH NON-DROWSY DAYTIME COLD AND FLU RELIEF SINGLE SERVE CUPS  DAYTIME
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-688
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 6 g
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	20 mg  in 6 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg  in 6 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISOMALT (UNII: S870P55O2W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-688-08	8 in 1 CARTON	08/15/2016	07/22/2019
1		6 g in 1 CUP, UNIT-DOSE; 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	08/15/2016	07/22/2019

Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 7/2019

Document Id: f94bcd29-9f87-4367-a957-ed7b379b174f

34390-5

Set id: 200f5aef-dcc8-4f08-af66-0f7ff880493e

Version: 3

Effective Time: 20190726