OTC - PURPOSE SECTION
Homeopathic Decongestant/Bronchodilator Medicine
0.17 fl oz
(5 mL)
Pleo ® Ut "S" DROPS 6X
- Manufacturer
- Sanum Kehlbeck GmbH & Co. KG
- Effective date
- 2012-03-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:47
Label at a glance#
ProductPleo Ut S
Active ingredientmycobacterium phlei
Label structure8 sections
Label contents#
Full prescribing information#
Indications
For temporary relief of flu symptoms
OTC - ACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
INGREDIENTS
5 mL Mycobacterium phlei 6X in a base of purified water.
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.
DOSAGE
1-3 times weekly, 2–5 drops.
WARNING
If symptoms persist more than a few days, contact a licensed practitioner. As with other drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
STORAGE AND HANDLING SECTION
Protect from light and heat.
SPL UNCLASSIFIED SECTION
Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany
Distributed by:
SANUM USA Corp.,
1465 Slater Road,
Ferndale, WA 98248
Rev. 03/2010
PRINCIPAL DISPLAY PANEL - 5 mL Carton
Pleo® Ut
"S"
DROPS 6X
Homeopathic
Decongestant/
Bronchodilator
Medicine
The original
SANUM®
brand remedies
Indications: For
temporary relief
of flu symptoms
0.17 fl oz
(5 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60681-5401-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c0d7-f6ea-e053-dbdaa90aa703 | Pleo ® Ut "S" DROPS 6X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60681-5401-2 | Pleo Ut S | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 2 | |
| 60681-5401-2 | Pleo Ut S | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60681-5401 | PLEO UT S (MYCOBACTERIUM PHLEI) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG] | 2 | Legacy NDC, 2 package rows | 20120601_5a983921-a747-4584-b02b-a678fa7517d5.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| mycobacterium phlei | ACTIVE INGREDIENT | T67520T45F | 2 | |
| mycobacterium phlei | ACTIVE MOIETY | T67520T45F | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Pleo Ut S
- mycobacterium phlei
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60681-5401 | 60681-5401-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| mycobacterium phlei | T67520T45F | ACTIB |
| water | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e8630e4-ed27-41fa-a0a9-a4c9b844caaf | 5a983921-a747-4584-b02b-a678fa7517d5 | 2012-03-09 | Warnings | 4e8630e4-ed27-41fa-a0a9-a4c9b844caaf 5a983921-a747-4584-b02b-a678fa7517d5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.