FDA.reportPublic FDA data

Pleo Alkala Antacid

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2009-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:39

Label at a glance#

ProductPleo Alkala Antacid
Active ingredientsodium bicarbonate, potassium bicarbonate, sodium citrate
Label structure11 sections

Indications and uses

Relieves: Heartburn Sour stomach Acid indigestion Upset stomach associated with these symptoms

Dosage and administration

Use enclosed spoon. Take one spoonful in the morning with a glass of water. If needed, take a second spoonful in the evening, or as directed by a doctor. Do not take more than 2 spoonfuls in a 24-hour period. If you are over 60 years old, do not take more than 1 spoonful. Not for children under 12 years. Do not take maximum dose for more than 2 weeks.

Storage and handling

Do not use after expiration date. Store at room temperature. Protect from heat and light. Sodium per spoonful 1500 mg. Potassium per spoonful 190 mg.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

5.3 oz
(150 g)

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurposes
Potassium bicarbonate (7.8%)Antacid
Sodium bicarbonate (78%)Antacid
Sodium citrate (1.6%)Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves:

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

  • if you have kidney disease or are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if you are pregnant or nursing a baby.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if symptoms or maximum dosage lasts more than 2 weeks.
  • may have laxative effect or cause constipation in some users.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Tamper Evident

OTC - DO NOT USE SECTION

This container has been designed for your safety to ensure product freshness. Do not use after expiration date. Do not use if the seal between the cap and container is broken or missing or imprinted security strip on carton is torn.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use enclosed spoon. Take one spoonful in the morning with a glass of water. If needed, take a second spoonful in the evening, or as directed by a doctor.
  • Do not take more than 2 spoonfuls in a 24-hour period. If you are over 60 years old, do not take more than 1 spoonful. Not for children under 12 years.
  • Do not take maximum dose for more than 2 weeks.

Other information

STORAGE AND HANDLING SECTION

  • Do not use after expiration date.
  • Store at room temperature. Protect from heat and light.
  • Sodium per spoonful 1500 mg.
  • Potassium per spoonful 190 mg.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium lactate, sea salt, silica, sodium sulfate

SPL UNCLASSIFIED SECTION

Rev. 03/2007

Made in Germany by
Sanum-Kehlbeck GmbH
Germany

Distributed by:
SANUM USA Corp.
1465 Slater Road, Ferndale, WA 98248

PRINCIPAL DISPLAY PANEL - 150 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

"The Original"
Pleo™ Alkala
Antacid
Powder

5.3 oz
(150 g)

Principal Display Panel - 150 g Carton
Principal Display Panel - 150 g Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251782Pleo Alkala 7.8 % / 78 % / 1.6 % Powder for Oral SolutionPSN1
1251780potassium bicarbonate 7.8 % / sodium bicarbonate 78 % / sodium citrate 1.6 % Powder for Oral SolutionPSN1
1251782potassium bicarbonate 11700 MG / sodium bicarbonate 117000 MG / sodium citrate 2400 MG Powder for Oral Solution [Pleo Alkala]SBD1
1251780potassium bicarbonate 11700 MG / sodium bicarbonate 117000 MG / sodium citrate 2400 MG Powder for Oral SolutionSCD1
1251780K+ bicarbonate 11700 MG / NaHCO3 117000 MG / sodium citrate 2400 MG Powder for Oral SolutionSY1
1251782K+ bicarbonate 11700 MG / NaHCO3 117000 MG / sodium citrate 2400 MG Powder for Oral Solution [Pleo Alkala]SY1
1251782Pleo Alkala 7.8 % / 78 % / 1.6 % Powder for Oral SolutionSY1
1251780Pot bicarbonate 11700 MG / NaHCO3 117000 MG / sodium citrate 2400 MG Powder for Oral SolutionSY1
1251782Pot bicarbonate 11700 MG / NaHCO3 117000 MG / sodium citrate 2400 MG Powder for Oral Solution [Pleo Alkala]SY1
1251780potassium bicarbonate 7.8 % / sodium bicarbonate 78 % / sodium citrate 1.6 % Powder for Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-6001-12019-10-21C16284748780-1956f9ecf-dcf2-621f-e053-dbdaa90a74ad"The Original" Pleo™ Alkala Antacid Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-6001-1Pleo Alkala Antacid1 in 1 CARTONPOWDER11
60681-6001-1Pleo Alkala Antacid150 g in 1 BOTTLE, PLASTICPOWDER1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-6001PLEO ALKALA ANTACID (SODIUM BICARBONATE, POTASSIUM BICARBONATE AND SODIUM CITRATE) POWDER [SANUM KEHLBECK GMBH & CO. KG]1Legacy NDC, 2 package rows20091023_7dca3271-4810-45d0-8b02-0bb0941bcc6f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
potassium bicarbonateACTIVE INGREDIENTHM5Z15LEBN1
sodium bicarbonateACTIVE INGREDIENT8MDF5V39QO1
sodium citrateACTIVE INGREDIENT1Q73Q2JULR1
potassium cationACTIVE MOIETY295O53K1521
sodium cationACTIVE MOIETYLYR4M0NH371
calcium lactateINACTIVE INGREDIENT2URQ2N32W31
sea saltINACTIVE INGREDIENT87GE52P74G1
sodium sulfateINACTIVE INGREDIENT0YPR65R21J1

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
60681-600160681-6001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
sodium bicarbonate8MDF5V39QOACTIB
potassium bicarbonateHM5Z15LEBNACTIB
sodium citrate1Q73Q2JULRACTIB
calcium lactate2URQ2N32W3IACT
sea salt87GE52P74GIACT
sodium sulfate0YPR65R21JIACT

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 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium sulfateSODIUM SULFATE0YPR65R21JSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JSOAP / TOPICAL0.05 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JTABLET / ORAL182 mgExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JTABLET, COATED / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JSOLUTION/ DROPS / OPHTHALMIC13 mgExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JTABLET, DELAYED RELEASE / ORAL16.24 mgExact identifier — unii candidate
7 equally ranked IID candidates
sodium sulfateSODIUM SULFATE0YPR65R21JSOLUTION / OPHTHALMIC0.14 %w/vExact identifier — unii candidate
7 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
10098eed-072a-409e-8873-02a570e3c2857dca3271-4810-45d0-8b02-0bb0941bcc6f2009-10-16WarningsExact identifier
spl id: 10098eed-072a-409e-8873-02a570e3c285
spl set id: 7dca3271-4810-45d0-8b02-0bb0941bcc6f

Reported adverse events (FAERS/openFDA)#

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