CVS Health Daytime Severe Cough and Cold 6 Packets

Drug Labeling and Warnings

Drug Details [pdf]

CVS DAYTIME SEVERE COUGH AND COLD- acetaminophen, dextromethorphan, phenylephrine 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 Severe Cough and Cold 6 Packets

Active ingredients (in each packet)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Uses

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

Warnings

Liver warning: This product contains 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

• in a child under 4 years of age
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such 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 exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs fever, 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor

• Age:
  • Dose
• children under 4 years of age:
  • do not use
• children 4 to under 12 years of age:
  • do not use unless directed by a doctor
• adults and children 12 years of age and over:
  • one packet

Other information

• each packet contains: potassium 6mg
• store at controlled room temperature 20°-25oC (68°-77oF). Protect from excessive heat and moisture.

Inactive ingredients

blue# 1,citric acid, flavors, maltodextrin, potassium chloride, red # 40, silica ,sucralose, sucrose

Questions or Comments?

1-866-467-2748

Principal Display

CVS Health™

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

Severe

DAYTIME

SEVERE COUGH & COLD

ACETAMINOPHEN

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

• Nasal & sinus congestion
• Sore throat pain
• Cough
• Headache
• Body ache
• Fever

Berry Infused with Menthol & Green Tea Flavors

6 PACKETS

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

Daytime Severe Cough & Cold

CVS health™ Severe Cough & Cold Daytime provides complete relief of your cough and severe cold symptoms. This soothing hot liquid formula is alcohol free and tastes great.

For nighttime relief, try Severe Nighttime Cough & Cold.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & Cough

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-12431

CVS Quality

Money back Guarantee

CVS DAYTIME SEVERE COUGH AND COLD 
acetaminophen, dextromethorphan, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-776
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-776-06	6 in 1 CARTON	10/22/2015	07/22/2019
1		1 in 1 PACKET; 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	10/22/2015	07/22/2019

Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 7/2019

Document Id: 341671e7-cb14-4abe-ad6e-2000cbd89bf6

34390-5

Set id: b2b73836-c1c3-47b4-aeae-91b708b9a4b5

Version: 3

Effective Time: 20190725