CVS Nighttime Severe Cold and Flu Relief

Manufacturer
CVS Pharmacy
Effective date
2022-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:42:57

Label at a glance#

ProductCVS Nighttime Severe Cold and Flu Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure8 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage

Dosage and administration

■ do not take more than directed ■ empty each Single-Use Vial of all liquid when dosing. ■ use the chart below to confirm the dose Age (Years) Dose Children under 4 years old Do not use Children 4 to under 12 years old Ask a doctor Adults and children 12 years and over 1 Single Use Vial (30mL) every 4 hours while symptoms last Do not exceed 4 Single Use Vials in 24 hours

Label contents#

Full prescribing information#

Active Ingredients (in each Single-Use Vial, 30mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650mg

Dextromethorphan HBr, USP, 20mg

Doxylamine succinate, USP, 12.5mg

Phenylephrine HCl, USP, 10mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/ Fever reducer

Cough suppressant

Antihistamine

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 vials in 24 hours which is the maximum daily amount for this product ■ 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

OTC - DO NOT USE SECTION

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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 ■ to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease

■ diabetes ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ you get nervous, dizzy or sleepless ■ pain, nasal congestion, or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ 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

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center 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

■ empty each Single-Use Vial of all liquid when dosing.

■ use the chart below to confirm the dose

Age (Years)Dose
Children under 4 years oldDo not use
Children 4 to under 12 years oldAsk a doctor
Adults and children 12 years and over

1 Single Use Vial (30mL) every 4 hours while symptoms last

Do not exceed 4 Single Use Vials in 24 hours

Other information

OTHER SAFETY INFORMATION

■ each single-use vial (30 mL) contains 31mg of sodium

■ Store at 20-25oC (68-77oF)

■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum

Question or Comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-49769842-497-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f086cd95-dca6-2a90-e053-2a95a90ab826c1876de6-f869-ba6a-e053-2a95a90a2b982022-12-23WarningsExact identifier
spl id: f086cd95-dca6-2a90-e053-2a95a90ab826
spl set id: c1876de6-f869-ba6a-e053-2a95a90a2b98

Reported adverse events (FAERS/openFDA)#

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