FDA Label for Simply Shift
View Indications, Usage & Precautions
Simply Shift Product Label
The following document was submitted to the FDA by the labeler of this product Nartex Laboratorios Homeopaticos, S.a. De C.v.. 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 Ingredients
Passiflora incarnata 1X HPUS*
Valeriana officinalis 1X HPUS*
Arnica montana 12X HPUS*
Purpose
Passiflora incarnata 1X HPUS*......................Sleeplessness from worries and restlessness
Valeriana officinalis 1X HPUS*.......................Restless sleep
Arnica montana 12X HPUS*...........................Fatigue
*The letters "HPUS" indicate that the compoentns in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.
Uses
For the temporary relief of fatigue and lethargy and the restoration of a natural sleep pattern disturbed by long commutes, night shifts, travel or Jet Lag. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.
Warnings
- If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlining medical illness.
- Do not take this product for pain for more than 10 days unless directed by a doctor. If pain persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
Otc - Do Not Use
Do not use
- if you have an allergy or hypersensitivity to the componetns of the formula or have had a prior reaction to this product.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens.
- symptoms persist for more than 7 days or clear up and occur again within a few days.
- rash develops.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, consult a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
- children under 12 years, consult a physician.
Other Information
- store in a cool and dry place.
- do not use if container seal is broken.
Inactive Ingredients
Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP
Questions Or Comments?
[email protected] or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.
Package Label.Principal Display Panel
NDC 34666-404-01
SIMPLY Shift
Sleep Cycle Restoration
associated to long commutes, night shifts, travel or Jet Lag
- Feel refreshed and rested
- Stay Calm
- Reduce fatigue and lethargy
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evalluated and not clinically tested.
Homeopathic
Nighttime sleep aid
120 Tablets
* Please review the disclaimer below.