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  5. Label Information: Dormin

FDA Label for Dormin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. KEEP OUT OF REACH OF CHILDREN
    3. USES
    4. WARNINGS
    5. ASK DOCTOR
    6. ASK DOCTOR/PHARMACIST
    7. WHEN USING
    8. STOP USE
    9. PREGNANCY OR BREAST FEEDING
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Dormin Product Label

The following document was submitted to the FDA by the labeler of this product Randob Labs,ltd.. 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.

Active Ingredient



Diphenhydramine Hydrochloride


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 right away.


Uses



  • ▪helps to reduce difficulty falling asleep

Warnings



  • ▪Do not use
  • ▪in children under 12 years of age
  • ▪with any other product containing diphenhydramine, even one used on skin

Ask Doctor



As a doctor before use if you have

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

Ask Doctor/Pharmacist



As a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using



When using this product

  • ▪avoid alcoholic drinks

Stop Use



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


Pregnancy Or Breast Feeding



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


Directions



Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age


Other Information



  • ▪keep in dry place

    • Use by expiration date on pack


Inactive Ingredients



FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.


Principal Display Panel



Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

* Please review the disclaimer below.