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  5. Label Information: Sleep Aid

FDA Label for Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USE
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Velocity Pharma 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.

Other



Drug Facts


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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist 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.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



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 overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 yearsdo not use

Other Information



  • each caplet contains: calcium 15 mg
  • store between 20-25 °C (68-77 °F). Avoid high humidity. Protect from light.
  • do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken

Inactive Ingredients



carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


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