Daytime Cold And Flu And Nighttime Cold And Flu
FDA Label NDC 49738-037

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kmart Corporation for the product Daytime Cold And Flu And Nighttime Cold And Flu (NDC 49738-037). 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 cold & flu formula day non-drowsyactive ingredients (in each softgel), cold & flu formula nightactive ingredients (in each softgel), purposes, uses, warnings, do not use, ask a doctor before use if you have, 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

Cold & Flu Formula Day Non-Drowsyactive Ingredients (In Each Softgel)

Acetaminophen 325 mg 
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Cold & Flu Formula Nightactive Ingredients (In Each Softgel)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 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

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
    • runny nose and sneezing (Nighttime only)
    • temporarily reduces fever

Warnings

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. (Nighttime only)

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
  • in children under 12 years of age  

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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   
  • glaucoma (Nighttime only)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Stop Use And Ask A Doctor If

  • 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  

Keep Out Of Reach Of Children.

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

  • 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 15°-30°C (59°-86°F). Avoid excessive heat (Nighttime only).

Day Cold & Flu Formulainactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Nighttime Cold & Flu Formulainactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions Or Comments?

Call toll free: 1-800-842-7886

Principal Display Panel

daytime cold & flu and nighttime cold & flu 20 ct

NDC 49738-037-08

*Compare to the active ingredients in Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

* Please review the disclaimer below.