Daytime Nighttime Severe Cold and Flu

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2023-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:39:51

Label at a glance#

ProductDaytime Nighttime Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE
Label structure12 sections

Indications and uses

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

Dosage and administration

DAYTIME do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter adults and children 12 years and over 30 mL every 4 hours  children 6 to under 12 years  15 mL every 4 hours  children 4 to under 6 years ask a doctor  children under 4 years  do not u...

Storage and handling

DAYTIME each 15 mL contains: sodium 12 mg store between 20-25ºC (68-77º). Do not refrigerate NIGHTTIME each 30 mL contains: sodium 64 mg store between 20-25ºC (68-77ºF). Do not refrigerate

Label contents#

Full prescribing information#

Active ingredients  (in each 15 mL) DAYTIME

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients for (in each 30 mL) NIGHTTIME

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCL 10 mg

Purposes for Day Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Night Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

DAYTIME

  • temporarily relieves common cold and flu symptoms 
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pain
    • headache
    • fever
    • sore throat
    • reduces swelling of nasal passages
    • cough due to minor throat and bronchial irritation
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

NIGHTTIME

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

Warnings

WARNINGS SECTION

DAYTIME

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

NIGHTTIME

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.

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

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

DAYTIME

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

NIGHTTIME

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

DAYTIME

do not take more than directed.

NIGHTTIME

  • do not take 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

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
  • 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.

NIGHTTIME

  • 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

DAYTIME NIGHTTIME

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

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL= milliliter


NIGHTTIME

  • take only as directed (see Overdose warning)
  • Do not exceed 4 doses per 24 hours
  • 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
  • when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

DAYTIME

  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77º). Do not refrigerate

NIGHTTIME

  • each 30 mL contains: sodium 64 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Day Time 

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum

Night Time 

anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® AND NYQUIL® SEVERE COLD & FLU*

SEVERE Cold & Flu Relief

DAYTIME

Acetaminophen (Pain Reliever / Fever Reducer)

Dextromethorphan  HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCI (Nasal Decongestant)

Relieves

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

For ages 6 years and over

Max Strength

Non-Drowsy

Alcohol Free

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

NIGHT TIME

Acetaminophen (Pain Reliever / Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Doxylamine Succinate (Antihistamine)

Phenylephrine HCL (Nasal Decongestant)

Relieves

  • Headache, Fever, Sore Throat, Minor Aches & Pain
  • Nasal/Sinus Congestion & Sinus Pressure
  • Sneezing
  • Runny Nose
  • Cough

Max Strength

Alcohol Free

FL OZ (mL)

BERRY FLAVOR

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and NyQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTRIBUTED BY

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-813-162023-01-20C16284748780-1d6a99b39-84c8-a426-e053-dadaa90af4c2Drug Facts
55319-813-162022-01-28C16284748780-1d6a99b39-84c8-a426-e053-dadaa90af4c2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-813DAYTIME NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL DOXYLAMINESUCINATE) KIT [FAMILY DOLLAR (FAMILY WELLNESS)]2Legacy NDC20230122_f80b321f-fcef-4a07-a82c-28c0f99d13f8.zip

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-81355319-813-16

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DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ba3d93b3-dbfb-4a68-86a6-32212b8e1cc9f80b321f-fcef-4a07-a82c-28c0f99d13f82023-01-20WarningsExact identifier
spl id: ba3d93b3-dbfb-4a68-86a6-32212b8e1cc9
spl set id: f80b321f-fcef-4a07-a82c-28c0f99d13f8

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