FDA Label for Only For Sleep

View Indications, Usage & Precautions

Only For Sleep Product Label

The following document was submitted to the FDA by the labeler of this product O4 Global Trading Usa, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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