1. Home
  2. Labeler Index
  3. Topco Associates Llc
  4. 76162-159
  5. Label Information: Topcare Sleep Aid

FDA Label for Topcare Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    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. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Topcare Sleep Aid 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.

Active Ingredient (In Each Tablet)



Doxylamine succinate 25 mg


Purpose



Nighttime sleep-aid


Use



  • •helps to reduce difficulty in falling asleep

Do Not Use



  • •in children under 12 years of age
  • •with any other product containing doxylamine
  • •unless you have time for a full night’s sleep

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

Ask A Doctor Or Pharmacist Before Use If You Are



taking

  • •a sedative or any other sleep-aid
  • •tranquilizers
  • •any other antihistamines
  • •any other drugs

When Using This Product



  • •avoid alcoholic beverages
  • •do not drive a motor vehicle or operate machinery
  • •take only at bedtime

Stop Use And Ask A Doctor If



  • •sleeplessness persists continuously for more than two 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 of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • •children under 12 years of age: do not use

Other Information



  • •store at 20-25◦C (68-77◦F)
  • •keep carton. It contains important information.

Inactive Ingredients



anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate


Questions Or Comments?



1-888-423-0139


Package/Label Principal Display Panel



TopCare® health

COMPARE TO VICKS® ZZZQUIL® ULTRA ACTIVE INGREDIENT

NIGHTTIME

Sleep Aid

ULTRA

DOXYLAMINE SUCCINATE TABLETS, 25 mg

NIGHTTIME SLEEP-AID

Clinically Tested, Proven Effective

24 TABLETS

actual size

1 Tablet Dose

Sleep Aid Carton Image 1 - image 01

Sleep Aid Carton Image 1 - image 01


* Please review the disclaimer below.