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  5. Label Information: Sleep Aid Nighttime

FDA Label for Sleep Aid Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 400 TABLET BOTTLE LABEL

Sleep Aid Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007


Active Ingredient (In Each Tablet)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

Do Not Use



  • to make a child sleepy
  • 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



  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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


Directions



  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
    adults and children 12 years and over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use

Other Information



  • each tablet contains: calcium 18.64 mg
  • store between 20-25°C (68-77°F)
  • avoid excessive heat, cold and humidity
  • close cap tightly after use

Inactive Ingredients



crosscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide


Questions?



call 1-888-577-8033


Principal Display Panel - 400 Tablet Bottle Label



TopCare
health®

NDC 36800-148-40

COMPARE TO BENADRYL® ALLERGY
ULTRATAB® TABLETS ACTIVE INGREDIENT*

Allergy
Relief

DIPHENHYDRAMINE HCl 25 mg
ANTIHISTAMINE

RELIEF OF:

• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

400 TABLETS

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label - sleep 01

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label - sleep 01


* Please review the disclaimer below.