CVS Health Daytime 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 Health Daytime Severe Cold and Flu Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections

Indications and uses

temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial pa...

Dosage and administration

Directions ■ do not take more than directed ■ empty each Single-Use Vial of all liquid when dosing. ■ use the chart below to confirm 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 2 Single Use Vials (15 mL) Every 4 hours while symptoms last Do not exceed 8 Single Use Vials in 24 hours

Label contents#

Full prescribing information#

Active Ingredients (in each Single-Use Vial, 15mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 325mg

Dextromethorphan HBr, USP, 10mg

Guaifenesin, USP 200mg

Phenylephrine HCl, USP, 5mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/ Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 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

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 enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 use more than directed

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

Directions

■ do not take more than directed

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

■ use the chart below to confirm 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

2 Single Use Vials (15 mL) Every 4 hours while symptoms last

Do not exceed 8 Single Use Vials in 24 hours

Other information:

OTHER SAFETY INFORMATION

■ each single-use vial (15 mL) contains 16mg 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
69842-49969842-499-08

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
f086bb5a-6280-74fa-e053-2a95a90abd06c183a8dc-7f6b-72b6-e053-2995a90a9db42022-12-23WarningsExact identifier
spl id: f086bb5a-6280-74fa-e053-2a95a90abd06
spl set id: c183a8dc-7f6b-72b6-e053-2995a90a9db4

Reported adverse events (FAERS/openFDA)#

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