PANCREATINUM (oryctolagus cuniculus- rabbit pancreatin liquid

PANCREATINUM by

Drug Labeling and Warnings

PANCREATINUM by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Formula

Each Drop Contains: Oryctolagus cuniculus (Rabbit) Pancreatin 4CH

PURPOSE

Indications

For the temporary relief of symptoms
associated with gastrointestinal
discomforts.

WARNINGS

Warnings
If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. If symptoms persist or worsen, consult your healthcare practitioner.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a healthcare professional before use.

OVERDOSAGE

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

OTHER SAFETY INFORMATION

Do not use if seal is missing or broken. Store in a cool, dry place.

INACTIVE INGREDIENT

Inactive ingredients: Ethanol (beet), purified water

DOSAGE & ADMINISTRATION

Directions
Adults and Children (over 12 years): Take 10 drops two to three times daily.*
Children (1-12 years): Take three to five drops two to three times daily.*
*Take for three weeks, then one week off and three weeks on for three months or as recommended by your healthcare practitioner. Evaluate after three months.

INDICATIONS & USAGE

Indications

For the temporary relief of symptoms associated with gastrointestinal discomforts.

Directions
Adults and Children (over 12 years): Take 10 drops two to three times daily.*
Children (1-12 years): Take three to five drops two to three times daily.*
*Take for three weeks, then one week off and three weeks on for three months or as recommended by your healthcare practitioner. Evaluate after three months.

PRINCIPAL DISPLAY PANEL

UNDA

NDC: 62106-0287-0

PANCREATINUM

4CH

Homeopathic Remedy

Contians 30% Alcohol

1 fl oz (30 ml)

INGREDIENTS AND APPEARANCE

PANCREATINUM 
oryctolagus cuniculus (rabbit) pancreatin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-0287
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ORYCTOLAGUS CUNICULUS PANCREATIN (UNII: 34QK0IZ9HO) (ORYCTOLAGUS CUNICULUS PANCREATIN - UNII:34QK0IZ9HO)	ORYCTOLAGUS CUNICULUS PANCREATIN	4 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-0287-0	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/18/2018

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-0287)