Maximum Strength Cold Tabs Capsule, Coated
FDA Label NDC 73598-1342

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhk Dba American Safety & First Aid for the product Maximum Strength Cold Tabs (NDC 73598-1342). 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 other, otc - purpose, use, liver warning, sore throat warning, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Allergy warning: acetaminophen may cause severe skin reactions. Syhmptoms may include:

  • Skin reddening
  • Blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Otc - Purpose

Active ingredient (In Each Caplet)Purpose
Acetaminophen 325 mgpain reliever/fever reducer
Dextromethorphan HBr 10 mgcough suppressant
Guaifenesin 100mgexpectorant
Phenylephrine HCl 5mgnasal decongestant

Use

Temporarily relieves these symptoms due to the common cold:

  • headache
  • fever
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

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

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 (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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.

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product do not exceed recommended use.

Otc - Stop Use

Stop use and ask doctor if:

  • nervousness, dizziness or sleeplessness occur
  • pain, cough or nasal congestion gets worse or lasts for 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over:
    • take 2 caplets every 4 hours
    • do not to take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor

Other Information

  • store at 25°C (77°F); excursions permitted between15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use if packet opened or torn

Inactive Ingredient

corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid,talc,titanium dioxide

Questions?

1-866-651-3660 Monday-Friday 8am-5pm EST

Principal Display Panel - 80 Caplet Packet Box

This product is not manufactured or distributed by McNeil-PPC, Inc.
Owner of the registered trademark Tylenol®.

Product #1342

Maximum Strength
Cold Tabs

Pain Reliever/Fever Reducer
Decongestant/Expectorant
Cough Suppressant

Active ingredient:
Acetaminophen,
Dextromethorphan,
Guaifenesin, Phenylephrine

  • Helps reduce congestion, sinus pain and pressure,
    cough, fever, minor aches and pain
  • These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper-evi-
    dent packets for safety and convenience.

    80 Caplets • 2 Caplets Per Packet

    Principal Display Panel (80 Caplet Packet Box)

    Principal Display Panel (80 Caplet Packet Box)

* Please review the disclaimer below.