Multi Symptom Severe Cold and Nighttime Severe Cold and Cough

Manufacturer
CVS Pharmacy,Inc.
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-08-18 02:02:15

Label at a glance#

ProductMulti Symptom Severe Cold and Nighttime Severe Cold and Cough
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure25 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, while symptoms persist; Do not to take 6 packets in 24 hours or as directed by a doctor   Age   Dose   Adults and children 12 years of age   One packet   Children under 12 years of age   Do not use ▪ do not use more than directed ▪ take every 4 hours while symptoms persist;; not to exceed 5 packets in 24 hours or as directed by a doctor   Age   Dose   Adults an...

Storage and handling

▪ each packet contains: potassium 6 mg ▪ store at controlled room temperature. Protect from excessive heat and moisture.

Label contents#

Full prescribing information#

Active ingredients (in each packet) – Multi Symptom Severe Cold

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Active ingredients (in each packet) - Nighttime Severe Cold and Cough

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold and Cough

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses - Multi Symptom Severe Cold

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

Uses - Nighttime Severe Cold and Cough

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

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 - Multi Symptom Severe Cold

OTC - DO NOT USE SECTION

  • in a child under 12 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.

Do not use - Nighttime Severe Cold and Cough

OTC - DO NOT USE SECTION

  • in a child under 12 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.
  • with any other product containing diphenhydramine, even one used on skin
  • 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 a doctor before use if you have - Multi Symptom Severe Cold

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 before use if you have - Nighttime Severe Cold and Cough

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium restricted diet
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 - Multi Symptom Severe Cold

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product - Multi Symptom Severe Cold

OTC - WHEN USING SECTION

do not exceed recommended dosage

When using this product - Nighttime Severe Cold and Cough

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

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 professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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 – Multi Symptom Severe Cold

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours, while symptoms persist; Do not to take 6 packets in 24 hours or as directed by a doctor
  1. Age
  1. Dose
  1. Adults and children 12 years of age
  1. One packet
  1. Children under 12 years of age
  1. Do not use

Directions Nighttime Severe Cold and Cough

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours while symptoms persist;; not to exceed 5 packets in 24 hours or as directed by a doctor
  1. Age
  1. Dose
  1. Adults and children 12 years of age
  1. One packet
  1. Children under 12 years of age
  1. Do not use
  • 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 - Multi Symptom Severe Cold

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 6 mg
  • store at controlled room temperature. Protect from excessive heat and moisture.

Other information - Nighttime Severe Cold and Cough

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients - Multi Symptom Severe Cold

INACTIVE INGREDIENT SECTION

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

Inactive ingredients - Nighttime Severe Cold and Cough

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL

Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold* & Theraflu® Nighttime Severe Cold & Cough*

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

NIGHTTIME

Severe Cold & Cough

ACETAMINOPHEN - Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl – Antihistamine; Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

  • Nasal congestion
  • Sore throat pain
  • Cough
  • Headache
  • Body ache
  • Fever
  • Runny nose
  • Sneezing

Honey Lemon Flavor Infused with Chamomile &White Tea Flavors

6 PACKETS

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2017 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

Money Back Guarantee

*These products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold and Theraflu® Nighttime Severe Cold & Cough.

CVS Health Multi symptom severe cold and cough relief
CVS Health Multi symptom severe cold and cough relief

DailyMed Product Concepts#

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Products#

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DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-76859779-768-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-12-08full-release2026-06-01 01:20:41

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
ndc (package): 59779-768-12
ndc (product): 59779-768
ndc11 (package): 59779076812
spl id: ccf96f1f-17ff-4785-a0af-47e6fd36aa3b
spl set id: 91063edd-1e7e-41e9-8412-b14ef3749018

Reported adverse events (FAERS/openFDA)#

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