NightTime Cold and Flu

Manufacturer
CVS Pharmacy
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:52:50

Label at a glance#

ProductNightTime Cold and Flu
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves there symptoms due to a cold minor aches and pains headache sore throat runny nose sneezing itchy, watery eyes due to hay fever nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours children under 12 years of age; do not use 

Storage and handling

each 30 mL contains : potassium 10 mg each 30 mL contains : sodium 14 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves there symptoms due to a cold
    • minor aches and pains
    • headache
    • sore throat
    • runny nose
    • sneezing
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • itching of the nose or throat
    • 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

  • to make a child sleepy
  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 take more than directed (see overdose warning)
  • do not take more than 6 doses (180 mL) in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 4 hours
  • children under 12 years of age; do not use 

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: potassium 10 mg
  • each 30 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Severe Cold & Cough relief

ACETAMINOPHEN

Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl

Antihistamine; Cough Suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relief of:

Nasal congestion; Runny nose; Cough; Fever; Body ache; Sore throat; Headache

NIGHTTIME

Berry Flavor

Alcohol content 10%

For Ages 12 & Over

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by GSK Consumer Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS HEALTH Severe Cold & Cough Berry Flavor
CVS HEALTH Severe Cold & Cough Berry Flavor

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-693NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) LIQUID [CVS PHARMACY]6Legacy NDC20241013_e2fe7302-4b36-4f8b-870e-513c2382ee2d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-693-08ML - Milliliter59779-693acf96f30-b4c7-4dc8-8eaf-5997b490f5d012022-08-04

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-69359779-693-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
6fdbd447-b16f-4eb4-a86f-49f52e14ef53e2fe7302-4b36-4f8b-870e-513c2382ee2d2024-10-11WarningsExact identifier
spl id: 6fdbd447-b16f-4eb4-a86f-49f52e14ef53
spl set id: e2fe7302-4b36-4f8b-870e-513c2382ee2d

Reported adverse events (FAERS/openFDA)#

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