SPL v1
SPL
SPL Set ID e9c24994-b935-36e6-e053-2a95a90a78df
Route
ORAL
Published
Effective Date 2022-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-28

Description

Active ingredients (HPUS): Calendula officinalis 12X Carbo vegetablis 12X Chamomilla 12X Foeniculum vulgare 12X Lycopodium 30X Nux moschata 12X Zingiber officinalen 12X Cell Salts: Kali muriaticum 6X Magnesia phosphorica 12X Natrum phosphoricum 6X

Purpose

Uses: Temporarily relieves infant discomfort caused by minor stomach pain upset stomach nervous tummy diarrhea colic gas indigestion excessive stomach acid nausea stomach presuure and cramps


Medication Information

Purpose

Uses: Temporarily relieves infant discomfort caused by

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

Active ingredients (HPUS): Calendula officinalis 12X Carbo vegetablis 12X Chamomilla 12X Foeniculum vulgare 12X Lycopodium 30X Nux moschata 12X Zingiber officinalen 12X Cell Salts: Kali muriaticum 6X Magnesia phosphorica 12X Natrum phosphoricum 6X

Usage

Temporarily relieves:

  • Diarrhea
  • Stomach Acid
  • Gas & Bloating
  • Upset Stomach
  • Nervous Tummy

Dosage

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, every 2 hours thereafter.

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*

*Reduce frequency when symptoms improve.

Warning

Warnings:

Stop use and ask doctor if:

  • fever develops
  • diarrhea lasts more than 2 days
  • other symtomps persist for more than 7 days or worse
Pregnant

If pregnant or breastfeeding, consult your doctor before use.

Questions

Questions or comments? Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST

Instruction

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,

every 2 hours thereafter

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours

*Reduce frequency when symptoms improve.

Ask A Doctor
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
    condition.
Active Ingredient

Active ingredients (HPUS):

  • Calendula officinalis 12X
  • Carbo vegetablis 12X
  • Chamomilla 12X
  • Foeniculum vulgare 12X
  • Lycopodium 30X
  • Nux moschata 12X
  • Zingiber officinalen 12X

Cell Salts:

  • Kali muriaticum 6X
  • Magnesia phosphorica 12X
  • Natrum phosphoricum 6X
Inactive Ingredient

Inactive ingredients: Apple juice, citric acid, glycerin, potassium sorbate, purified water

Principal Display Panel

Label Display Panel

Keep Out of Reach of Children

Keep out of reach

of children. In case of overdose (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

Usage

Temporarily relieves:

  • Diarrhea
  • Stomach Acid
  • Gas & Bloating
  • Upset Stomach
  • Nervous Tummy

Dosage

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, every 2 hours thereafter.

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*

*Reduce frequency when symptoms improve.

Purpose

Uses: Temporarily relieves infant discomfort caused by

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

Warnings:

Stop use and ask doctor if:

  • fever develops
  • diarrhea lasts more than 2 days
  • other symtomps persist for more than 7 days or worse
Pregnant

If pregnant or breastfeeding, consult your doctor before use.

Questions

Questions or comments? Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST

Instruction

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,

every 2 hours thereafter

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours

*Reduce frequency when symptoms improve.

Ask A Doctor (Ask a Doctor)
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
    condition.
Active Ingredient

Active ingredients (HPUS):

  • Calendula officinalis 12X
  • Carbo vegetablis 12X
  • Chamomilla 12X
  • Foeniculum vulgare 12X
  • Lycopodium 30X
  • Nux moschata 12X
  • Zingiber officinalen 12X

Cell Salts:

  • Kali muriaticum 6X
  • Magnesia phosphorica 12X
  • Natrum phosphoricum 6X
Inactive Ingredient

Inactive ingredients: Apple juice, citric acid, glycerin, potassium sorbate, purified water

Principal Display Panel

Label Display Panel

Keep Out of Reach of Children (Keep Out of Reach Of Children)

Keep out of reach

of children. In case of overdose (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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