Digestive Enzyme Formula

Manufacturer
Nutritional Specialties, Inc.
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:30

Label at a glance#

ProductDigestive Enzyme Formula
Active ingredientBOS TAURUS GALLBLADDER, HEPARIN, BOVINE, PORK INTESTINE, SUS SCROFA PANCREAS, SUS SCROFA RECTAL MUCOSA, SUS SCROFA STOMACH
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Gallbladder 6X, 12X, 30X, Hepar 6X, 12X, 30X, Intestine 6X, 12X, 30X, Pancreas Suis 6X, 12X, 30X, Rectal Mucosa 6X, 12X, 30X, Stomach 6X, 12X, 30X.

PURPOSE:

OTC - PURPOSE SECTION

Aids in temporary relief of minor digestive disorders and provides enzymatic help.†

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

WARNINGS:

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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 & USAGE SECTION

Aids in temporary relief of minor digestive disorders and provides enzymatic help.†

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0111-1

DIGESTIVE

ENZYME

FORMULA

2 FL. OZ (60 ml)

DIGESTIVE ENZYME FORMULADIGESTIVE ENZYME FORMULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0111-1Digestive Enzyme Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0111DIGESTIVE ENZYME FORMULA (GALLBLADDER (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), PANCREAS SUIS, RECTAL MUCOSA (SUIS), STOMACH (SUIS)) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20231006_7234c2b2-0bac-47c8-87e1-785f0d13a0f8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-011183027-0111-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Digestive Enzyme FormulaGALLBLADDER (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), PANCREAS SUIS, RECTAL MUCOSA (SUIS), STOMACH (SUIS)Nutritional Specialties, Inc.7234c2b2-0bac-47c8-87e1-785f0d13a0f82023-10-05WarningsExact identifier
ndc (package): 83027-0111-1
ndc (product): 83027-0111
ndc11 (package): 83027011101
spl id: 72677556-e646-41cd-b53a-10043664b87c
spl set id: 7234c2b2-0bac-47c8-87e1-785f0d13a0f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.