FDA Label for Calms Nerve Tension Sleeplessness
View Indications, Usage & Precautions
Calms Nerve Tension Sleeplessness 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.
Otc - Purpose
Temporary symptomatic treatment for relief of simple nervous tension & occasional sleeplessness.
Homeopathic Formula
PASSIFLORA 1X Triple Strength HPUS (Passion Flower)
AVENA SATIVA 1X Double Strength HPUS (Oat)
HUMULUS LUPULUS 1X Double Strength HPUS (Hops)
CHAMOMILLA 2X HPUS (Chamomile)
“HPUS” indicates the active
ingredients are in the official
Homeopathic Pharmacopoeia
of the United States.
Inactive Ingredient
Lactose N.F.,
Starch (Corn and Tapioca),
Vegetable Magnesium Stearate.
Otc - Do Not Use
Do not use if imprinted cap band is missing or broken.
Otc - Ask Doctor
If symptoms persist for more than seven days or worsen, consult a Health Care Professional.
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of reach of children.
Adults & Children 12 And Over:
As a relaxant: Swallow 1-2 tablets with water as needed 3 times daily. For occasional sleeplessness:
1-3 tablets 1/2 to 1 hour before retiring.
Children 6-12 Years:
As a relaxant: 1 tablet with water as needed 3 times daily. For occasional sleeplessness: 1-2 tablets 1 hour before retiring.
Questions?
CALL US:
(800) 624-9659
Principal Display Panel - 100 Tablet Bottle Carton
NDC 54973-1120-3
Hyland's®
Calms
Simple Nerve Tension
& Occasional Sleeplessness*
Temporary symptomatic
treatment for relief of simple
nervous tension & occasional
sleeplessness.
NON-HABIT FORMING
100 4 g TABLETS
* Please review the disclaimer below.