SPL v3
SPL
SPL Set ID 91c1e0ae-9999-0ae2-e053-2995a90a2d71
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Activated Charcoal (12 [hp_X]) Nutmeg (6 [hp_X]) Potassium Cation (30 [hp_X]) Matricaria Recutita Calendula Officinalis Flowering Top Sodium Cation Lycopodium Clavatum Spore Ginger Magnesium Cation Fennel Seed
Inactive Ingredients
Apple Juice Citric Acid Monohydrate Glycerin Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-10

Description

Active Ingredients Calendula officinalis 12X HPUS Carbo Vegetabilis 12X HPUS Chamomilla 12X HPUS Foeniculum Vulgare 12X HPUS Lycopodium 30X HPUS Nux Moschata 12X HPUS Zingiber Officinale 12X HPUS Cell Salts Kali muriaticum 6X HPUS Magnesia phosphorica 12X HPUS Natrum phosphoricum 6X HPUS

Purpose

Purpose Upset stomach Nausea and vomiting Abdominal pain associated with nervousness Upset stomach Gas, diarrhea Indigestion Stomach hyperacidity Abdominal inflammation Abdominal colic type pain Stomach hyperacidity


Medication Information

Purpose

Purpose

Upset stomach

Nausea and vomiting

Abdominal pain associated with nervousness

Upset stomach

Gas, diarrhea

Indigestion

Stomach hyperacidity

Abdominal inflammation

Abdominal colic type pain

Stomach hyperacidity

Description

Active Ingredients Calendula officinalis 12X HPUS Carbo Vegetabilis 12X HPUS Chamomilla 12X HPUS Foeniculum Vulgare 12X HPUS Lycopodium 30X HPUS Nux Moschata 12X HPUS Zingiber Officinale 12X HPUS Cell Salts Kali muriaticum 6X HPUS Magnesia phosphorica 12X HPUS Natrum phosphoricum 6X HPUS

Uses

Uses

Temporarily relieves infant discomfort caused by

  • gas
  • colic
  • nausea
  • stomach pressure and cramps
  • diarrhea
  • upset stomach
  • nervous tummy
  • indigestion
  • minor stomach pain
  • excessive stomach acid

Warnings

Stop use and ask doctor if:

  • fever develops
  • diarrhea lasts more than 2 days
  • other symptoms persist for more than 7 days or worsen
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Active Ingredient

Active Ingredients

Calendula officinalis 12X HPUS

Carbo Vegetabilis 12X HPUS

Chamomilla 12X HPUS

Foeniculum Vulgare 12X HPUS

Lycopodium 30X HPUS

Nux Moschata 12X HPUS

Zingiber Officinale 12X HPUS

Cell Salts

Kali muriaticum 6X HPUS

Magnesia phosphorica 12X HPUS

Natrum phosphoricum 6X HPUS

Inactive Ingredients

Inactive ingredients

Apple juice, citric acid, glycerin, potassium sorbate, purified water

Principal Display Panel

Pregnancy Or Breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children

Keep out of reach of children. in case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Structured Label Content

Uses

Uses

Temporarily relieves infant discomfort caused by

  • gas
  • colic
  • nausea
  • stomach pressure and cramps
  • diarrhea
  • upset stomach
  • nervous tummy
  • indigestion
  • minor stomach pain
  • excessive stomach acid

Purpose

Purpose

Upset stomach

Nausea and vomiting

Abdominal pain associated with nervousness

Upset stomach

Gas, diarrhea

Indigestion

Stomach hyperacidity

Abdominal inflammation

Abdominal colic type pain

Stomach hyperacidity

Warnings

Stop use and ask doctor if:

  • fever develops
  • diarrhea lasts more than 2 days
  • other symptoms persist for more than 7 days or worsen
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Active Ingredient

Active Ingredients

Calendula officinalis 12X HPUS

Carbo Vegetabilis 12X HPUS

Chamomilla 12X HPUS

Foeniculum Vulgare 12X HPUS

Lycopodium 30X HPUS

Nux Moschata 12X HPUS

Zingiber Officinale 12X HPUS

Cell Salts

Kali muriaticum 6X HPUS

Magnesia phosphorica 12X HPUS

Natrum phosphoricum 6X HPUS

Inactive Ingredients

Inactive ingredients

Apple juice, citric acid, glycerin, potassium sorbate, purified water

Principal Display Panel

Pregnancy Or Breastfeeding (Pregnancy or breastfeeding)

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. in case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Advanced Ingredient Data


Raw Label Data

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