FDA.reportPublic FDA data

CVS Health Multi Symptom Severe Cold

Manufacturer
CVS Pharmacy,Inc.
Effective date
2019-07-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:54

Label at a glance#

ProductCVS Health Multi Symptom Severe Cold MULTI SYMPTOM SEVERE COLD
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and 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

Dosage and administration

• 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. • ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Multi-Symptom Severe Cold 6 Packets
CVS Health Multi-Symptom Severe Cold 6 Packets

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN3
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD3
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY3
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY3
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428524091GTIN-13: 0050428524091
EAN-13: 0050428524091
GTIN-12: 050428524091
UPC-A: 050428524091
GTIN storage (14 digits): 00050428524091		image-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-877-062021-01-29C16284748780-1ba0f9c33-59c1-a910-e053-dadaa90a0b85CVS Health Multi-Symptom Severe Cold Green Tea and Honey Lemon Flavors 6 Packets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-877-06CVS Health Multi Symptom Severe ColdMULTI SYMPTOM SEVERE COLD6 in 1 CARTONPOWDER, FOR SOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-877CVS HEALTH MULTI SYMPTOM SEVERE COLD MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [CVS PHARMACY,INC.]3Legacy NDC, 1 package rows20190724_1dad0528-e99f-45b8-a072-3c6249bf2bcd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-87759779-877-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARAMELT9D99G2B1RIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f40f7967-3e3b-48dd-8b04-c998f85d67f11dad0528-e99f-45b8-a072-3c6249bf2bcd2019-07-24WarningsExact identifier
spl id: f40f7967-3e3b-48dd-8b04-c998f85d67f1
spl set id: 1dad0528-e99f-45b8-a072-3c6249bf2bcd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.