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Drug Facts
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Similasan Corp., Highlands Ranch, CO 80129
Gas And Colic Plus Stomach Cramps Baby
FDA Label NDC 59262-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Gas And Colic Plus Stomach Cramps Baby (NDC 59262-503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, usesthese statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Chamomilla 12X | stomach pressure, gas, irritability, sleeplessness, crying |
| Cocculus indicus 15X | stomach cramps, colic, flatulence, disturbed sleep |
| Colocynthis 12X | cramps, stomach pressure and pain, sleeplessness, bloating |
| Lycopodium 15X | flatulence, bloating, colic (esp. evenings), irritability, restlessness |
| Magnesia phosphorica 12X | stomach cramps, hiccups |
Usesthese Statements Are Based Upon Traditional Homeopathic Principles. They Have Not Been Reviewed By The Food And Drug Administration
According to homeopathic principles, the active ingredients in this product temporarily relieve the symptoms associated with gas, colic and stomach cramps caused by irritating food, feeding too quickly, swallowing air and similar conditions.
Warnings
- According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
- If conditions worsen or persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.
- Consult a physician if the following symptoms occur: vomiting, change in stool, fever, lethargy, or poor weight gain.
- Do not exceed recommended dosage.
- As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.
Directions
Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Do not use if tamper evident seal beneath cap is broken or missing.
For more information, see http://www.similasanUSA.com/about-homeopathy
Inactive Ingredients
Crospovidone, Mannitol, Sodium stearyl fumarate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com
Principal Display Panel - 135 Tablet Bottle Carton
NDC 59262-503-26
Similasan®
Gas & Colic
+ Stomach
Cramps
Formulated with
NATURAL ACTIVE INGREDIENTS
BABY
- Chamomile for Irritability*
- Salt of Magnesia for Stomach Cramps*
- No Artificial Flavors, Dyes or Preservatives
HOMEOPATHIC
Based on Original
Swiss Formula
135 Quick Dissolving
Tablets (actual size)
Principal Display Panel (135 Tablet Bottle Carton)
* Please review the disclaimer below.
