Non Drowsy Day And Night Multi-symptom Cold And Flu Formula
FDA Label NDC 55319-615

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Non Drowsy Day And Night Multi-symptom Cold And Flu Formula (NDC 55319-615). 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 softgel), purposes, uses, other, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Softgel)

Equate Health COLD & FLU FORMULA DAY NON-DROWSY

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Equate Health COLD & FLU FORMULA NIGHT

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purposes

DAY COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

DAY COLD & FLU FORMULA

temporarily relieves these symptoms due to a cold or flu:
minor aches and pains
headache
cough
sore throat
nasal and sinus congestion
temporarily reduces fever

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Other

Liver warning

DAY COLD & FLU FORMULA

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels 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


    • 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.

    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.

      NIGHTTIME COLD & FLU FORMULA

      Liver warning

      These products contain acetaminophen. Severe liver damage may occur if you take

      • more than 10 softgels 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

        • 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.

        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.

          Do not use to sedate children.

          Distributed by:
          MIDWOOD BRANDS, LLC
          500 Volvo Pkwy
          Chesapeake, VA 23320 USA

Do Not Use

DAY COLD & FLU FORMULA

  • 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
  • in children under 12 years of age

    • NIGHTTIME COLD & FLU FORMULA

    • 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
    • in children under 12 years of age

Ask A Doctor Before Use If You Have

DAYTIME COLD & FLU FORMULA

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    • NIGHTTIME COLD & FLU FORMULA

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

When Using This Product

DAYTIME COLD & FLU FORMULA

When using this product do not exceed recommended dosage

NIGHTTIME COLD & FLU FORMULA

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

DAYTIME COLD & FLU FORMULA

  • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs

      • NIGHTTIME COLD &FLU  FORMULA

      • pain, cough, or nasal congestion 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.

        • nervousness, dizziness, or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

If pregnant or breast-feeding, ask a health professional before use.

Directions

DAY COLD & FLU FORMULA

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

    • NIGHTTIME COLD & FLU FORMULA

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use

Other Information

  • store at room temperature. Avoid excessive heat.

Inactive Ingredients

DAY COLD & FLU FORMULA

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

NIGHTTIME COLD & FLU FORMULA

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene, glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol
sorbitan, sodium hydroxide, titanium dioxide

Questions Or Comments?

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