SPL v1
SPL
SPL Set ID e8bee190-04b2-4be6-e053-2a95a90a30a0
Route
ORAL
Published
Effective Date 2022-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-28

Description

Active ingredients (HPUS) Carbo vegetabilis 12X Chamomilla 12X Foeniculum vulgare 12X Lycopodium 30X Nux moschata 12X Raphanus sativus 12X Zingiber officinale 12X Cell Salts Kali muriaticum 6X Magnesia phosphorica 12X Natrum phosphoricum 6X

Purpose

Temprorily Relieves: Colic Gas Pain Stomach & Gas Discomfort Irritability from Gas Stomach Acid Buildup


Medication Information

Purpose

Temprorily Relieves:

  • Colic Gas Pain
  • Stomach & Gas Discomfort
  • Irritability from Gas
  • Stomach Acid Buildup
Description

Active ingredients (HPUS) Carbo vegetabilis 12X Chamomilla 12X Foeniculum vulgare 12X Lycopodium 30X Nux moschata 12X Raphanus sativus 12X Zingiber officinale 12X Cell Salts Kali muriaticum 6X Magnesia phosphorica 12X Natrum phosphoricum 6X

Uses

Uses: Temporarily relieves infant discomfort caused by

  • gas
  • nausea
  • fussiness
  • colic
  • indigestion
  • burping
  • groaning
  • restlesness
  • sleeplessness
  • diarrhea
  • crying
  • constipation
  • ecxessive stomach acid
  • bloating
  • stomach discomfort and presure
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.

Warnings

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.
Pregnancy

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

Ask A Doctor

Ask a doctor before use if you are taking a prescription drugs or have a serious medical condition.

Please consult your physician immiediately for a worsening condition.

Active Ingredients

Active ingredients (HPUS)

Carbo vegetabilis 12X

Chamomilla 12X

Foeniculum vulgare 12X

Lycopodium 30X

Nux moschata 12X

Raphanus sativus 12X

Zingiber officinale 12X

Cell Salts

Kali muriaticum 6X

Magnesia phosphorica 12X

Natrum phosphoricum 6X

Inactive Ingredients

Inactive ingredients

Apple juice, citric acid, glycerin, potassium

sorbate, purified water

Principal Display Panel

Label Display:

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

Uses

Uses: Temporarily relieves infant discomfort caused by

  • gas
  • nausea
  • fussiness
  • colic
  • indigestion
  • burping
  • groaning
  • restlesness
  • sleeplessness
  • diarrhea
  • crying
  • constipation
  • ecxessive stomach acid
  • bloating
  • stomach discomfort and presure
Dosage (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.

Purpose (PURPOSE)

Temprorily Relieves:

  • Colic Gas Pain
  • Stomach & Gas Discomfort
  • Irritability from Gas
  • Stomach Acid Buildup
Warnings (WARNINGS)

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.
Pregnancy (PREGNANCY)

If pregnant or breastfeeding, consult your doctor before use.

Questions (QUESTIONS)

Questions or comments?

Call us at 1-855-366-7755 (U.S.A. only)

M-F 8am-5pm CST

Ask A Doctor (ASK A DOCTOR)

Ask a doctor before use if you are taking a prescription drugs or have a serious medical condition.

Please consult your physician immiediately for a worsening condition.

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (HPUS)

Carbo vegetabilis 12X

Chamomilla 12X

Foeniculum vulgare 12X

Lycopodium 30X

Nux moschata 12X

Raphanus sativus 12X

Zingiber officinale 12X

Cell Salts

Kali muriaticum 6X

Magnesia phosphorica 12X

Natrum phosphoricum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients

Apple juice, citric acid, glycerin, potassium

sorbate, purified water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Label Display:

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

All Sections (JSON)