Gas And Colic Plus Stomach Cramps Baby

Gas And Colic Plus Stomach Cramps Baby
SPL v2
SPL
SPL Set ID f3eef109-5fdf-43bc-a315-256e58a0a5ff
Route
ORAL
Published
Effective Date 2018-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (12 [hp_X]) Anamirta Cocculus Whole (15 [hp_X]) Citrullus Colocynthis Fruit Pulp Lycopodium Clavatum Spore Magnesium Cation
Inactive Ingredients
Crospovidone, Unspecified Sodium Stearyl Fumarate Mannitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-06-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1
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
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

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

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com

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

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)

Usesthese Statements Are Based Upon Traditional Homeopathic Principles. They Have Not Been Reviewed By the Food and Drug Administration

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.


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
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
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

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

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com

Other Information (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 (Inactive ingredients)

Crospovidone, Mannitol, Sodium stearyl fumarate

Principal Display Panel 135 Tablet Bottle Carton (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)

Usesthese Statements Are Based Upon Traditional Homeopathic Principles. They Have Not Been Reviewed By the Food and Drug Administration (UsesThese statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration)

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.


Advanced Ingredient Data


Raw Label Data

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