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  5. Label Information: Sleep Aid

FDA Label for Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    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. PRINCIPAL DISPLAY PANEL

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets 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 Caplet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



for relief of occasional sleeplessness


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
  • •trouble urinating due to an enlarged prostate gland
  • •glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • •avoid alcoholic drinks
  • •drowsiness may 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.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



adults and children 12

years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use


Other Information



  • •each caplet contains: calcium 15 mg
  • •store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • •do not use if blister unit is broken or torn (Blister Pack)
  • •do not use if printed seal under cap is broken or missing (Carton)

Inactive Ingredients



carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide


Principal Display Panel



sleepaid

DIPHENHYDRAMINE HCl 25mg

NIGHTTIME SLEEP AID

non-habit-forming

contains no pain reliever

ACTUAL SIZE

24 CAPLETS

Compare to the Active Ingredient in Simply Sleep® Nighttime Sleep Aid


* Please review the disclaimer below.