FDA.reportPublic FDA data

Dr Wises Formula II Intestinal Calm

Manufacturer
Apotheca Company
Effective date
2022-04-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:03:17

Label at a glance#

ProductDr Wises Formula II Intestinal Calm
Active ingredientLYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:  Lycopodium clavatum 12X, Pulsatilla 12X.

OTC - PURPOSE SECTION

INDICATIONS:  For temporary relief of symptoms associated with constipation, bloating, diarrhea and other symptoms of poor digestion.

WARNINGS SECTION

WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.  Consult a physician for use in children under 12 years of age.

If you have an allergy to fish (including Salmon), you should not use this product.

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

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

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  Adults take 6 capsules one time daily.  Children under 30 lbs take 3 capsules one time daily, up to 60 lbs take 3 capsules one time daily, up to 90 lbs take 4 capsules one time daily.  Can take capsule apart and mix powder in juice.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  Aronia (Berry), Gelatin, DNA (Deoxyribonucleic acid)*, Folic acid, L-carnosine, Rice flour, RNA (Ribonucleic acid), Vitamin D3 (from Cholecalciferol).

* Contains Salmon

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

INDICATIONS:  For temporary relief of symptoms associated with constipation, bloating, diarrhea and other symptoms of poor digestion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

J and L HEALTH

Dr. Wise's Formula II Intestinal Calm

Homeopathic

180 Capsules

Dr. Wise's Formula II Intestinal CalmDr. Wise's Formula II Intestinal Calm

Dr. Wise's Formula II Intestinal CalmDr. Wise's Formula II Intestinal Calm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0176-12022-04-19C16284748780-19d75b9cf-ffbf-f424-e053-dadaa90a57ceDr. Wise's Formula II Intestinal Calm
57520-0176-12020-01-31C16284748780-19d75b9cf-ffbf-f424-e053-dadaa90a57ceDr. Wise's Formula II Intestinal Calm

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
ARONIA MELANOCARPA FRUITINACTIVE INGREDIENTS935718Z2Q1
CARNOSINEINACTIVE INGREDIENT8HO6PVN24W1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
FOLIC ACIDINACTIVE INGREDIENT935E97BOY81
GELATININACTIVE INGREDIENT2G86QN327L1
HERRING SPERM DNAINACTIVE INGREDIENT51FI676N6F1
RICEINACTIVE INGREDIENT659G217HPG1
SACCHAROMYCES CEREVISIAE RNAINACTIVE INGREDIENTJ17GBZ5VGX1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57520-017657520-0176-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
CARNOSINE8HO6PVN24WIACT
CHOLECALCIFEROL1C6V77QF41IACT
FOLIC ACID935E97BOY8IACT
BROWN RICE659G217HPGIACT
GELATIN2G86QN327LIACT
ARONIA MELANOCARPA FRUITS935718Z2QIACT
SACCHAROMYCES CEREVISIAE RNAJ17GBZ5VGXIACT
HERRING SPERM DNA51FI676N6FIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates

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
558faa29-2161-4c05-95b2-8ab7d6c5d1bd9ab34b8b-9173-4c40-bb49-c9b096200c402022-04-19WarningsExact identifier
spl id: 558faa29-2161-4c05-95b2-8ab7d6c5d1bd
spl set id: 9ab34b8b-9173-4c40-bb49-c9b096200c40

Reported adverse events (FAERS/openFDA)#

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