PLEO ALKALA ANTACID- sodium bicarbonate, potassium bicarbonate and sodium citrate powder 
Sanum Kehlbeck GmbH & Co. KG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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"The Original"
Pleo™ Alkala
Antacid
Powder

5.3 oz
(150 g)

Drug Facts

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

Uses

Relieves:

Warnings

Ask a doctor or pharmacist before use

  • 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

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

Keep out of reach of children.

Tamper Evident

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

Other information

Inactive ingredients

calcium lactate, sea salt, silica, sodium sulfate

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

"The Original"
Pleo™ Alkala
Antacid
Powder

5.3 oz
(150 g)

Principal Display Panel - 150 g Carton
PLEO ALKALA ANTACID 
sodium bicarbonate, potassium bicarbonate and sodium citrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium bicarbonate (UNII: 8MDF5V39QO) (sodium cation - UNII:LYR4M0NH37) sodium bicarbonate11.70 g  in 150 g
potassium bicarbonate (UNII: HM5Z15LEBN) (potassium cation - UNII:295O53K152) potassium bicarbonate117 g  in 150 g
sodium citrate (UNII: 1Q73Q2JULR) (sodium cation - UNII:LYR4M0NH37) sodium citrate2.4 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
calcium lactate (UNII: 2URQ2N32W3)  
sea salt (UNII: 87GE52P74G)  
sodium sulfate (UNII: 0YPR65R21J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-6001-11 in 1 CARTON
1150 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: 10098eed-072a-409e-8873-02a570e3c285
Set id: 7dca3271-4810-45d0-8b02-0bb0941bcc6f
Version: 1
Effective Time: 20091016
 
Sanum Kehlbeck GmbH & Co. KG