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 disintegrating

Gas and Colic Plus Stomach Cramps Baby by

Drug Labeling and Warnings

Gas and Colic Plus Stomach Cramps Baby by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

1 These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

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.

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 getinfo@similasanusa.com. www.SimilasanUSA.com

SPL UNCLASSIFIED SECTION

Distributed by:
Similasan Corp., Highlands Ranch, CO 80129

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)

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 disintegrating

Product 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)