SPL v2
SPL
SPL Set ID df8e8995-3106-4b21-acc4-24eeefd109fc
Route
ORAL
Published
Effective Date 2018-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Citrullus Colocynthis Fruit Pulp (6 [hp_X]) Magnesium Cation Matricaria Chamomilla Dioscorea Villosa Root
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Acetate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-03

Description

Active Ingredients HPUS : Colocynthis 6X    (Bitter apple) Magnesia phosphorica 6X    (Magnesium hydrogen phosphate) Chamomilla 6X    (German chamomille) Dioscorea villosa 6X    (Wild yam) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States)


Medication Information

Warnings and Precautions

Warnings

Do not use if bottle seal is broken

or missing,

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for

more than 2 days.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of

ingredients traditionally used to help relieve symptoms

associated with colic*   •intestinal gas  •abdominal pain

•bloating  •nausea  •burping

Dosage and Administration

Directions

Children udner 6 months of age: consult a licensed

healthcare practitioner before using this product

Children 6 months to 2 years old: 0.5 ml orally every 8

hours or 3 times a day

Children 2 to 9 years old: 0.75 ml orally every 8 hours or

3 times a day

Description

Active Ingredients HPUS : Colocynthis 6X    (Bitter apple) Magnesia phosphorica 6X    (Magnesium hydrogen phosphate) Chamomilla 6X    (German chamomille) Dioscorea villosa 6X    (Wild yam) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States)

Section 44425-7

Other information

Store at room temperature

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients

Purified water, sorbitol, raspberry

and grape flavor, sodium

benzoate, potassium sorbate,

citric acid.

Section 55105-1

Purpose

Colocynthis 6X...........................................abdominal bloating, colic and nausea

(Bitter apple)

Magnesia phosphorica 6X ----------------------abdominal cramps

(Magnesium hydrogen phosphate)

Chamomilla 6X ..........................................nausea, agitation and irritability

(German chamomille)

Dioscorea villosa 6X ...................................intestinal gas, burping and colic-like pain

(Wild yam)

Section 55106-9

Active Ingredients HPUS:

Colocynthis 6X

   (Bitter apple)

Magnesia phosphorica 6X

   (Magnesium hydrogen phosphate)

Chamomilla 6X

   (German chamomille)

Dioscorea villosa 6X

   (Wild yam)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States)

Kids Relief Gas & Colic Oral Liquid


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of

ingredients traditionally used to help relieve symptoms

associated with colic*   •intestinal gas  •abdominal pain

•bloating  •nausea  •burping

Dosage and Administration (34068-7)

Directions

Children udner 6 months of age: consult a licensed

healthcare practitioner before using this product

Children 6 months to 2 years old: 0.5 ml orally every 8

hours or 3 times a day

Children 2 to 9 years old: 0.75 ml orally every 8 hours or

3 times a day

Warnings and Precautions (34071-1)

Warnings

Do not use if bottle seal is broken

or missing,

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for

more than 2 days.

Section 44425-7 (44425-7)

Other information

Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified water, sorbitol, raspberry

and grape flavor, sodium

benzoate, potassium sorbate,

citric acid.

Section 55105-1 (55105-1)

Purpose

Colocynthis 6X...........................................abdominal bloating, colic and nausea

(Bitter apple)

Magnesia phosphorica 6X ----------------------abdominal cramps

(Magnesium hydrogen phosphate)

Chamomilla 6X ..........................................nausea, agitation and irritability

(German chamomille)

Dioscorea villosa 6X ...................................intestinal gas, burping and colic-like pain

(Wild yam)

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Colocynthis 6X

   (Bitter apple)

Magnesia phosphorica 6X

   (Magnesium hydrogen phosphate)

Chamomilla 6X

   (German chamomille)

Dioscorea villosa 6X

   (Wild yam)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States)

Kids Relief Gas & Colic Oral Liquid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)