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  5. Label Information: Nighttime Sleep Aid

FDA Label for Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

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

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Heb. 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 Tablet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



helps to reduce difficulty falling asleep


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


Otc - When Using



When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Otc - Stop Use



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.


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 of age and over: take two tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years of age:  do not use

Other Information



  • each tablet contains: calcium 85 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose


Questions Or Comments?



1-844-705-4384


Principal Display Panel



Compare to Sominex® Tablets active ingredient†

HEB®

NDC 37808-019-02

Original Formula

Nighttime Sleep-Aid

Diphenhydramine HCl

25 mg

Helps you fall asleep

Safe, effective & non-habit forming

Actual Size

32 TABLETS

image description - F101902HEB R0

image description - F101902HEB R0


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