Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 992e6f61-abc9-4146-a9da-5ada4a627aa7
Route
ORAL
Published
Effective Date 2023-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Betaine (6 [hp_X]) Hydrochloric Acid (12 [hp_X]) Phosphate Ion Sus Scrofa Pancreas Sus Scrofa Stomach Comfrey Root Pepsin
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-10-04

Description

Betainum Muriaticum 6X, Muriaticum Acidum 6X, Natrum Phosphoricum 6X, Pancreas Suis 6X, Stomach 6X, Symphytum Officinale 6X, Pepsinum 12X.

Purpose

Aids in stimulating and balancing stomach enzyme release.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in stimulating and balancing stomach enzyme release.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Betainum Muriaticum 6X, Muriaticum Acidum 6X, Natrum Phosphoricum 6X, Pancreas Suis 6X, Stomach 6X, Symphytum Officinale 6X, Pepsinum 12X.

Purpose:

Aids in stimulating and balancing stomach enzyme release.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications:

Aids in stimulating and balancing stomach enzyme release.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Betainum Muriaticum 6X, Muriaticum Acidum 6X, Natrum Phosphoricum 6X, Pancreas Suis 6X, Stomach 6X, Symphytum Officinale 6X, Pepsinum 12X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0106-1

STOMACH

ENZYME

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

Aids in stimulating and balancing stomach enzyme release.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Aids in stimulating and balancing stomach enzyme release.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Betainum Muriaticum 6X, Muriaticum Acidum 6X, Natrum Phosphoricum 6X, Pancreas Suis 6X, Stomach 6X, Symphytum Officinale 6X, Pepsinum 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0106-1

STOMACH

ENZYME

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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