BABY GAS AND COLIC PLUS STOMACH CRAMPS- atropa belladonna, matricaria recutita, anamirta cocculus whole, citrullus colocynthis fruit pulp and magnesium phosphate, dibasic trihydrate tablet, orally disintegrating

Baby Gas and Colic Plus Stomach Cramps by

Drug Labeling and Warnings

Baby Gas and Colic Plus Stomach Cramps 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

Belladonna 12X

Purpose

stomach pressure, abdominal pain, gas

Active Ingredient

Chamomilla 12X

Purpose

gas, colic, irritability, sleeplessness, crying

Active Ingredient

Cocculus indicus 15X

Purpose

stomach cramps, colic, flatulence, disturbed sleep

Active Ingredient

Colocynthis 12X

Purpose

cramps, stomach pressure and pain, sleeplessness

Active Ingredient

Magnesia phosphorica 12X

Purpose

stomach cramps, gas, hiccups, burping, bloating

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve the symptoms associated with gas and colic caused by irritating food, feeding too quickly, swallowing air and similar conditions such as:

• gas discomfort
  
• colic
  
• stomach cramps
  
• stomach pressure
  
• hiccups
  
• crying
  
• irritability

Warnings:

• Initial exacerbation of symptoms may occur.
  
• 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.
  
• Consulta 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.

Inactive Ingredients:

Kollidon CL, Mannitol, Sodium stearyl fumarate

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-501-26
Similasan®
Gas & Colic +
Stomach Cramps
BABY
135 Quick Dissolving
Tablets

INGREDIENTS AND APPEARANCE

BABY GAS AND COLIC PLUS STOMACH CRAMPS 
atropa belladonna, matricaria recutita, anamirta cocculus whole, citrullus colocynthis fruit pulp and magnesium phosphate, dibasic trihydrate tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	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]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

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: 59262-501-26	1 in 1 BOX
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		01/01/2015

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan Corporation		111566530	MANUFACTURE(59262-501)