FDA.reportPublic FDA data

Gas and Colic Plus Stomach Cramps Baby

Manufacturer
Similasan Corporation
Effective date
2018-07-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:23

Label at a glance#

ProductGas and Colic Plus Stomach Cramps Baby
Active ingredientMatricaria Chamomilla, Anamirta Cocculus Whole, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, Magnesium Phosphate, Dibasic Trihydrate
Label structure10 sections

Indications and uses

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.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Chamomilla 12Xstomach pressure, gas, irritability, sleeplessness, crying
Cocculus indicus 15Xstomach cramps, colic, flatulence, disturbed sleep
Colocynthis 12Xcramps, stomach pressure and pain, sleeplessness, bloating
Lycopodium 15Xflatulence, bloating, colic (esp. evenings), irritability, restlessness
Magnesia phosphorica 12Xstomach cramps, hiccups

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • 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 SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

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 www.similasanUSA.com/about-homeopathy

Inactive ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, Mannitol, Sodium stearyl fumarate

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-503-262020-01-31C16284748780-19d75b9d0-e680-f424-e053-dadaa90a57ceGas and Colic Plus Stomach Cramps Baby

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-503-26Gas and Colic Plus Stomach Cramps Baby135 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1352
59262-503-26Gas and Colic Plus Stomach Cramps Baby1 in 1 BOXTABLET, ORALLY DISINTEGRATING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-503GAS 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 [SIMILASAN CORPORATION]2Legacy NDC, 2 package rows20180803_f3eef109-5fdf-43bc-a315-256e58a0a5ff.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-50359262-503-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Matricaria ChamomillaG0R4UBI2ZZACTIB
Anamirta Cocculus Whole8O4P2U3QO2ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
Magnesium Phosphate, Dibasic TrihydrateHF539G9L3QACTIB
Crospovidone, Unspecified2S7830E561IACT
Sodium Stearyl Fumarate7CV7WJK4UIIACT
Mannitol3OWL53L36AIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
626cb8f1-202a-4328-9cdd-076cbf330199f3eef109-5fdf-43bc-a315-256e58a0a5ff2018-07-30WarningsExact identifier
spl id: 626cb8f1-202a-4328-9cdd-076cbf330199
spl set id: f3eef109-5fdf-43bc-a315-256e58a0a5ff

Reported adverse events (FAERS/openFDA)#

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