daytime nightime severe cold

Manufacturer
CVS Pharmacy
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:34:19

Label at a glance#

Productdaytime nightime severe cold
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • cough • minor aches and pains • headache • nasal congestion • sore throat • sinus congestion and pressure • runny nose (NIGHT TIME only) • sneezing (NIGHT TIME only) • itching of the nose or throat (NIGHT TIME only) • itchy, watery eyes due to hay fever (NIGHT TIME only) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial pas...

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 over: 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 COLD & FLU only) • store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet) DAY TIME COLD & FLU

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes - Day Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each caplet) NIGHT TIME COLD & FLU

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purposes - Night Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • sinus congestion and pressure
  • runny nose (NIGHT TIME only)
  • sneezing (NIGHT TIME only)
  • itching of the nose or throat (NIGHT TIME only)
  • itchy, watery eyes due to hay fever (NIGHT TIME only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
  • controls cough to help you get to sleep
  • 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 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
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT TIME only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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 only)

When using these products

OTC - WHEN USING SECTION

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

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). 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 10 caplets in any 24-hour period
  • adults and children 12 years of age and over: 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 COLD & FLU only)
  • store at 20-25°C (68-77°F)

Inactive ingredients (DAY TIME COLD & FLU)

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, FD&C blue #2 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

Controls cough

Thins & loosens mucus

Relieves nasal & chest congestion

Relieves aches, fever & sore throat

FOR AGES 12+

Actual Size

MAXIMUM STRENGTH

Nighttime

Severe Cold

Acetaminophen

Pain reliever, Fever reducer

Diphenhydramine HCl

Antihistamine, Cough Suppressant

Phenylephrine HCl

Nasal decongestant

MULTI-SYMPTOM

Controls cough

Relieves runny nose & sneezing

Relieves nasal congestion

Relieves aches, fever & sore throat

FOR AGES 12+

Actual Size

20 DAYTIME CAPLETS & 10 NIGHTTIME CAPLETS

TOTAL 30 CAPLETS

daytime severe cold nighttime severe cold image 1
daytime severe cold nighttime severe cold image 1
daytime nightime severe cold image 2
daytime nightime severe cold image 2

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
69842-73669842-736-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML · Source PDF

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
c0227543-52c5-4adf-94e2-36447a23ccaba40ee4ef-8515-4814-8567-365211f9d4e72020-07-27WarningsExact identifier
spl set id: a40ee4ef-8515-4814-8567-365211f9d4e7

Reported adverse events (FAERS/openFDA)#

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