Only For
FDA Label NDC 73006-111

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 73006-111). 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)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Uses:

for relief of occasional sleeplessness

Warnings:

Do not use:

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

    • Ask a doctor before use if you have:

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

      • Ask a doctor before use if you
      are taking sedatives or tranquilizers

      When using this product

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

        • Stop use and ask a doctor if
        sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

        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
     adults and children 12 years of age and over 2 caplets at bedtime if needed, or as directed by a doctor
     children under 12 years of age do not use

Other Information:

  • Store at room temperature between 20-25°C (68-77°F)
  • Avoid high humidity • Protect from light

Inactive Ingredients:

Croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Packaging

Onlyfor (Sleep)

Onlyfor (Sleep)

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