Tylenol Cold Flu Severe Tablet, Film Coated
FDA Label NDC 50269-550

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jc World Bell Wholesale Co., Inc. for the product Tylenol Cold Flu Severe (NDC 50269-550). 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 drug facts, active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • for the temporary relief of the following cold/flu symptoms:
  • minor aches and pains 
  • headache
  • sore throat
  • nasal congestion
  • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 reactions occurs, stop use and seek medical help right away.
    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompained 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.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

When Using This Product,

do not exceed recommended dose

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleepless occurs
  • 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,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning:In case of overdose, get medical helo or contact a Posion 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 directed (see overdose warning)
    •  adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole; do not crush, chew or dissolve
    • do not take more than 10 caplets in 24 hours
     children under 12 years ask a doctor

Other Information

  • each caplet contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C Yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

Questions Or Comments?

call 1-877-895-3665(toll-free) or 215-273-8755(collect)

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