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  5. Label Information: Nighttime Sleepaid

FDA Label for Nighttime Sleepaid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL - 12 CAPSULE CARTON

Nighttime Sleepaid Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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.

Other



Drug Facts

Exclusively distributed by:

Kareway Product, Inc.

2550 S. Dominguez Hills Dr.

Compton, CA  90220

Made in Korea


Active Ingredients (In Each Softgel)



Diphenhydramine HCl 25 mg


Purpose



nighttime sleep-aid


Uses



  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Otc - Do Not Use



Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Otc - Ask Doctor



Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid


Otc - When Using



When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating 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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)


Directions



  • take only one dose per day (24 hours) - see Overdose warning
    • adults & children
    12 yrs & over    		One dose = TWO 25 mg Softgels (50 mg)
    at bed time if needed or as directed by a doctor


Other Information



  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • Protect from light

Inactive Ingredients



FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water


* Please review the disclaimer below.