FDA.reportPublic FDA data

DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU

Manufacturer
CVS Pharmacy
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:30:42

Label at a glance#

ProductDAYTIME SEVERE COLD NIGHTTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • nasal congestion • cough (DAY TIME Severe Cold only) • minor aches and pains • headache • sore throat • runny nose and sneezing (NIGHT TIME Cold & Flu only) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only) • temporarily reduces fever

Dosage and administration

• do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

Storage and handling

• each caplet contains: sodium 4 mg (DAY TIME Severe Cold only) • store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet) - DAY TIME Severe Cold

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – NIGHT TIME Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes - DAY TIME Severe Cold

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes - NIGHT TIME Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough (DAY TIME Severe Cold only)
  • minor aches and pains
  • headache
  • sore throat
  • runny nose and sneezing (NIGHT TIME Cold & Flu only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only)
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: These products contain 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 these products

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.
  • with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only)
  • 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 these products.
  • if you have ever had an allergic reaction to these products or any of their ingredients

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
  • glaucoma (NIGHT TIME Cold & Flu only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME Severe Cold only)
  • cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)

When using these products

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT TIME Cold & Flu only)
  • marked drowsiness may occur (NIGHT TIME Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only)
  • avoid alcoholic drinks (NIGHT TIME Cold & Flu only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • 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. (DAY TIME Severe Cold only)

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 10 caplets in any 24-hour period
  • adults and children 12 years of age and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 4 mg (DAY TIME Severe Cold only)
  • store at 20-25°C (68-77°F)

Inactive ingredients - DAY TIME Severe Cold

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients – NIGHT TIME Cold & Flu

INACTIVE INGREDIENT SECTION

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Mucinex® Fast-Max® Day Time & Night Time

MAXIMUM STRENGTH

Daytime

Severe Cold

ACETAMINOPHEN

Pain reliever, Fever Reducer

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN – Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Multi-Symptom

Relieves aches, fever & sore throat

Relieves nasal & chest congestion

Controls cough

Thins & loosens mucus

For Ages 12 & Over

Actual Size

MAXIMUM STRENGTH

Nighttime

Cold & Flu

ACETAMINOPHEN

Pain reliever, Fever reducer

DIPHENHYDRAMINE HCl

Antihistamine

PHENYLEPHRINE HCl

Nasal decongestant

Multi-Symptom

Relieves aches, fever & sore throat

Relieves nasal congestion

Relieves runny nose & sneezing

For Ages 12 & Over

Actual Size

20 DAYTIME CAPLETS & 10 NIGHTTIME CAPLETS

TOTAL 30 CAPLETS

Severe Cold - Cold & Flu Image 1
Severe Cold - Cold & Flu Image 1
Severe Cold - Cold & Flu Image 2
Severe Cold - Cold & Flu Image 2
Severe Cold - Cold & Flu Image 3
Severe Cold - Cold & Flu Image 3

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-95169842-951-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
e6955774-6628-414b-81da-3826d388926df5fa92e4-2086-494e-90fa-e1ee232117e02022-12-20WarningsExact identifier
spl set id: f5fa92e4-2086-494e-90fa-e1ee232117e0

Reported adverse events (FAERS/openFDA)#

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