NDC | 59262-503-26 |
Set ID | f3eef109-5fdf-43bc-a315-256e58a0a5ff |
Category | HUMAN OTC DRUG LABEL |
Packager | Similasan Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
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 -
Uses1
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.
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- These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration
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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.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Carton
NDC 59262-503-26
Similasan®
Gas & Colic
+ Stomach
CrampsFormulated 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 Formula135 Quick Dissolving
Tablets (actual size) -
INGREDIENTS AND APPEARANCE
GAS AND COLIC PLUS STOMACH CRAMPS BABY
anamirta cocculus whole, citrullus colocynthis fruit pulp, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate and matricaria chamomilla tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59262-503 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Matricaria Chamomilla (UNII: G0R4UBI2ZZ) (Matricaria Chamomilla - UNII:G0R4UBI2ZZ) Matricaria Chamomilla 12 [hp_X] Anamirta Cocculus Whole (UNII: 8O4P2U3QO2) (Anamirta Cocculus Whole - UNII:8O4P2U3QO2) Anamirta Cocculus Whole 15 [hp_X] CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 12 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 12 [hp_X] Inactive Ingredients Ingredient Name Strength Crospovidone, Unspecified (UNII: 2S7830E561) Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI) Mannitol (UNII: 3OWL53L36A) Product Characteristics Color WHITE Score no score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59262-503-26 1 in 1 BOX 07/20/2018 1 135 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 06/15/2018 Labeler - Similasan Corporation (111566530)