Cvs Health Multi Symptom Severe Cold
FDA Label NDC 59779-877

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Multi Symptom Severe Cold (NDC 59779-877). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each packet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Packet)

Acetaminophen 500 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

    • 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask A 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
  • symptoms do not get better or worsen
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with 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 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

  • do not use more than directed
  • take every 4 hours ; not to exceed 6 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

    • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Other Information

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

Inactive Ingredients

anhydrous citric acid, caramel, flavors, maltodextrin ,potassium citrate, silica, sucralose, sucrose,

Questions Or Comments

1-866-467-2748

Principal Display

Cvs Health Multi-symptom Severe Cold 6 Packets (Image 01)

Cvs Health Multi-symptom Severe Cold 6 Packets (Image 01)

CVS Health™

Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*

Severe

NDC 59779-877-06

Multi-Symptom

Severe Cold

ACETAMINOPHEN

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

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

    • Green Tea & Honey Lemon Flavors

    6 PACKETS

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

    Multi-Symptom Severe Cold

    CVS Health™ Multi-Symptom Severe Cold provides complete relief of your severe cold symptoms. This soothing hot liquid formula is dye free, aspartame free and sodium free and tastes great.

    For nighttime relief, try CVS Health™ Nighttime Severe Cough & Cold.

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

    Dye, Aspartame, & Sodium free

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2015 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-12431

    CVS® Quality

    Money back Guarantee

    *This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Multi-Symptom Severe Cold

* Please review the disclaimer below.