Multi Sympton Cold Day Night
FDA Label NDC 67510-9156

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Multi Sympton Cold Day Night (NDC 67510-9156). 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 for night(in each tablet), active ingredients for day(in each tablet), purpose for night, purpose for day, uses, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients For Night(In Each Tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Active Ingredients For Day(In Each Tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purpose For Night

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Purpose For Day

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these common cold symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sneezing and runny nose (Night only)
  • sinus congestion and pressure (Day only)
  • helps clear nasal passages
  • relieves cough to help you sleep (Night only)
  • promotes nasal and sinus drainage (Day only)
  • temporarily reduces fever

Warnings

Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.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 product containing acetaminophen
  • 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are (Night Only)

taking sedatives or tranquilizers (Night only)

When Using This Product

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

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Enter section text here

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Stop Use And Ask A Doctor If

  • 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.

Directions

  • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 tablets every 4 hours
    • swallow whole - do not crush, chew or dissolve
    • do not take more than 12 tablets in 24 hours
    children under 12 years
    		Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage


Other Information

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive Ingredients

microcrystalline cellulose, lactose, hydroxypropyl cellulose, sodium starch glycolate, sillicon dioxide, magnesium stearate, hypromellose (Night only), bleu no.1 (Night only), titanium dioxide (Night only), polyethylene glycol (Night only), anhydrous citric acid, sodium citrate, ethanol, FDC Yellow no.5 (Day only),

Package Label

Image Of Carton Label (Multi.carton3)

Image Of Carton Label (Multi.carton3)

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