Only For
FDA Label NDC 73006-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O4 Global Trading Usa, Llc for the product Only For (NDC 73006-110). 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 ingredient (in each caplet), purpose, uses:, warnings:, keep out of reach of childern, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Caplet)

Acetaminophen 500mg

Caffeine 65mg

Purpose

Pain reliever

Pain reliever aid

Uses:

  • Temporarily relieves minor aches and pains due to:
  • headache      • muscular aches

Warnings:

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • 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 reaction occurs, stop use and seek medical help right away. 

    Caffeine warning:

    The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat. 

    Do not use

    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

      • Ask a doctor before use if

      you have liver disease

      Ask a doctor or pharmacist before use if,

      you are taking the blood thinning drug warfarin

      Stop use and ask a doctor if

      • any new symptoms occur     • pain gets worse or lasts for more than 10 days

      • fever gets worse or lasts for more than 3 days

      These could be signs of a serious condition

      If pregnant or breast-feeding,

      ask a health professional before use.

Keep Out Of Reach Of Childern

In case of accidental overdose, get medical help or contact a Poison Control Center 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:

  • take with a full glass of water
  • do not take more than directed
  • do not take more than 6 caplets in 24 hours
    •  adults and children 12 years of age and over take 2 caplets every 6 hours, not more than 6 caplets in 24 hours.
     under 12 years of age ask a doctor

Other Information:

  • Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments ?

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