1. Home
  2. Labeler Index
  3. Hyland's Inc.
  4. 54973-3206
  5. Label Information: Sleep

FDA Label for Sleep

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - STOP USE
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON

Sleep Product Label

The following document was submitted to the FDA by the labeler of this product Hyland's 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


Otc - Purpose



Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Hyoscyamus Niger 6X HPUS (0.0000001% Alkaloids)occasional nighttime sleeplessness
Ignatia Amara 6X HPUS (0.0000017% Alkaloids)anxiousness, worry
Kali Phosphoricum 3X HPUSwakefulness, occasional sleeplessness, nervousness

Uses



Temporarily relieves the symptoms of occasional nighttime sleeplessness and wakefulness due to nervousness, anxiousness, or worry.


Otc - Stop Use



Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.


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 accidental overdose, get medical help or contact a Poison Control Center immediately.


Directions



Adults and children 12 years and over: Dissolve 2-3 tablets under tongue 1/2 hour to 1 hour before retiring. Children 6 years to under 12 years: Dissolve 1-2 tablets under tongue 1/2 hour to 1 hour before retiring.


Other Information



  • do not use if imprinted tamper band is broken or missing
  • Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive Ingredients



Acacia Gum, Lactose N.F.


Questions Or Comments?



(800) 624-9659


Principal Display Panel - 100 Tablet Bottle Carton



NDC 54973-3206-1

Hyland's®

HOMEOPATHIC

Sleep

Natural Relief of Occasional
Sleeplessness and Nervousness*

100
TABLETS


* Please review the disclaimer below.