Day Time Nite Time Intense Flu Kit
FDA Label NDC 79481-4700

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Day Time Nite Time Intense Flu (NDC 79481-4700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 30 Ml)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Pain reliever/fever reducer

Cough suppressant

Uses

  • temporarily relieves common cold/flu symptoms:
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
    • temporarily relieves common cold/flu symptoms:
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever

Warnings

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.

      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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

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

    • taking the blood thinning drug warfarin

When Using This Product

  • 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

  • pain 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.
    • pain 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,

ask a health professional before use.

ask a health professional before use.

Keep Out Of Reach Of Children.

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.

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

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 3 doses (30 mL each) per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    • take only as directed – see Overdose warning
    • only use the dose cup provided
    • do not exceed 3 doses (30 mL each) per day (24 hrs)

      • adults & children 12 yrs & over

      30 mL every 6 hrs

      children 4 to under 12 yrs

      ask a doctor

      children under 4 yrs

      do not use

Other Information

  • each 30 mL contains: sodium 28 mg
  • store at 20-25°C (68-77°F)
    • each 30 mL contains: sodium 28 mg
    • store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol, anhydrous citric acid, benzyl alcohol, FD&C red no. 40, flavor, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

alcohol, anhydrous citric acid, benzyl alcohol, FD&C red no. 40, flavor, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

1-800-719-9260

Package/Label Principal Display Panel

meijer®

COMBO PACK

MULTI-SYMPTOM | INTENSE FLU RELIEF

meijer®

Day Time Intense Flu

Acetaminophen

Pain Reliever | Fever Reducer

Dextromethorphan HBr

Cough Suppressant

COMPARE TO VICKS® DAYQUIL® INTENSE FLU ACTIVE INGREDIENTS

6 HR

FEVER, HEADACHE, COUGH, SORE THROAT, BODY ACHES

BLACK CHERRY FLAVOR

ALCOHOL 10%

meijer®

Nite Time Intense Flu

Acetaminophen

Pain Reliever | Fever Reducer

Doxylamine Succinate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

COMPARE TO VICKS® NYQUIL® INTENSE FLU ACTIVE INGREDIENTS

6 HR

BODY ACHES, FEVER, HEADACHE, SORE THROAT, SNEEZING, RUNNY NOSE, COUGH

BLACK CHERRY FLAVOR

ALCOHOL 10%

BLACK CHERRY FLAVOR

2 - 12 FL OZ (355 mL) BOTTLES – 24 FL OZ (1.5 pt) (710 mL) TOTAL

Meijer-daytime-nitetime-intense-flu-carton-image.jpg (Meijer Daytime Nitetime Intense Flu Carton Image)

Meijer-daytime-nitetime-intense-flu-carton-image.jpg (Meijer Daytime Nitetime Intense Flu Carton Image)

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