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  5. Label Information: Sominex

FDA Label for Sominex

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL

Sominex Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company Inc.. 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



(in each tablet)

Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



helps reduce difficultly falling asleep


Do Not Use



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

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 Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating 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.



In case of accidental overdose get medical help or contact a Poison Control Center right away.


Directions



Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor


Inactive Ingredients



cellulose, microcrystalline, croscarmellose sodium, FD&C blue no. 1, hypromellose, lactose monohydrate, light mineral oil, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin


* Please review the disclaimer below.