Baby Gas and Colic Plus Stomach Cramps

Manufacturer: Similasan Corporation
Effective date: 2023-05-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:31:46

Label at a glance#

ProductBaby Gas and Colic Plus Stomach Cramps

Active ingredientATROPA BELLADONNA, MATRICARIA RECUTITA, ANAMIRTA COCCULUS WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE

Label structure19 sections

Indications and 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

Dosage and administration

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Contacts and useful links#

PhoneLabel contact1-800-240-9780

Websitewww.similasanusa.com

www.SimilasanUSA.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna 12X

Purpose

OTC - PURPOSE SECTION

stomach pressure, abdominal pain, gas

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 12X

Purpose

OTC - PURPOSE SECTION

gas, colic, irritability, sleeplessness, crying

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cocculus indicus 15X

Purpose

OTC - PURPOSE SECTION

stomach cramps, colic, flatulence, disturbed sleep

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colocynthis 12X

Purpose

OTC - PURPOSE SECTION

cramps, stomach pressure and pain, sleeplessness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesia phosphorica 12X

Purpose

OTC - PURPOSE SECTION

stomach cramps, gas, hiccups, burping, bloating

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a medical professional or a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Do not use if tamper evident seal beneath cap is broken or missing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Kollidon CL, Mannitol, Sodium stearyl fumarate

Questions?

OTC - QUESTIONS SECTION

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59262-501-26	2023-05-08	C162847	48780-1	9d75b9d0-2197-f424-e053-dadaa90a57ce	Baby Gas and Colic Plus Stomach Cramps
59262-501-26	2020-01-31	C162847	48780-1	9d75b9d0-2197-f424-e053-dadaa90a57ce	Baby Gas and Colic Plus Stomach Cramps

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59262-501-26	EA - Each	59262-501	db6c2c4a-c956-4976-b778-a77ad95c6cad	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
ANAMIRTA COCCULUS WHOLE	ACTIVE INGREDIENT	8O4P2U3QO2	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	2
CITRULLUS COLOCYNTHIS FRUIT PULP	ACTIVE INGREDIENT	23H32AOH17	2
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	ACTIVE INGREDIENT	HF539G9L3Q	2
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	2
ANAMIRTA COCCULUS WHOLE	ACTIVE MOIETY	8O4P2U3QO2	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	2
CITRULLUS COLOCYNTHIS FRUIT PULP	ACTIVE MOIETY	23H32AOH17	2
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	2
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Baby Gas and Colic Plus Stomach Cramps
atropa belladonna, matricaria recutita, anamirta cocculus whole, citrullus colocynthis fruit pulp and magnesium phosphate, dibasic trihydrate
ATROPA BELLADONNA
MATRICARIA RECUTITA
ANAMIRTA COCCULUS WHOLE
CITRULLUS COLOCYNTHIS FRUIT PULP
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
MAGNESIUM CATION
MANNITOL
SODIUM STEARYL FUMARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59262-501	59262-501-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
ANAMIRTA COCCULUS WHOLE	8O4P2U3QO2	ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP	23H32AOH17	ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	HF539G9L3Q	ACTIB
MANNITOL	3OWL53L36A	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT

Source Document#

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 82 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	POWDER, FOR SUSPENSION / ORAL	3.74 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / SUBCUTANEOUS		675 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET / SUBLINGUAL		29 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	980.4 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / OPHTHALMIC	3.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION/ DROPS / OPHTHALMIC	4.6 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		113 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / OPHTHALMIC	4.7 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAMUSCULAR		71 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	35 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	GRANULE / ORAL		77 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TROCHE / ORAL		14594 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS		180 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		543 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, ORALLY DISINTEGRATING / ORAL		153 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, EXTENDED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GEL / OPHTHALMIC		25 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL		1086 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		164 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, FILM COATED / ORAL		98 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE, FOR SUSPENSION / ORAL		6000 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		105 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, DELAYED RELEASE / ORAL		2043 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET, FOR SUSPENSION / ORAL		435 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	10.25 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / BUCCAL		360 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	CAPSULE, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	CAPSULE / ORAL		180 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	TABLET / ORAL		153 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GUM, CHEWING / BUCCAL		891 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAMUSCULAR	106.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	PELLET / ORAL		43 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SPRAY / NASAL	41.5 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE / ORAL		1562 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM STEARYL FUMARATE	SODIUM STEARYL FUMARATE	7CV7WJK4UI	LOZENGE / ORAL		125 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5fdbd552-5aad-418a-86ab-dfae29fa9a8a			ffcfc152-3232-4a88-9b78-e6981fc87684	2023-05-10	Warnings	Exact identifier spl id: 5fdbd552-5aad-418a-86ab-dfae29fa9a8a spl set id: ffcfc152-3232-4a88-9b78-e6981fc87684

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.