Only For
FDA Label NDC 73006-119

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 73006-119). 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 children, 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 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses:

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings:

Liver warning:

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

  • more than 1,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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.

    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.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • if you have ever had any allergic reaction to this product or any of its ingredients
    • 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   • a breathing problem such as emphysema or chronic bronchitis

      • trouble urinating due to an enlarged prostate gland   • glaucoma

      Ask a doctor before use if you are

      • taking the blood thinning drug warfarin    • taking sedatives or tranquilizers

      When using this product

      • drowsiness will occur  • avoid alcoholic drinks  • do not drive a motor vehicle or operate machinery

      Stop use and ask a doctor if

      • sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.   • pain gets worse or lasts more than 10 days

      • fever gets worse or last more than 3 days    • redness or swelling is present

      • new symptoms occur.

      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 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 (see Overdose Warning)
  • do not take more than 2 caplets in 24 hours
    • adults and children 12 years of age and over
    •  2 caplets at bedtime
    • do not take more than 2 caplets in 24 hours
     children under 12 years of age do not use

Other Information:

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

Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Packaging

Image Description (Label)

Image Description (Label)

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