Label: PLEO ALKALA ANTACID- sodium bicarbonate, potassium bicarbonate and sodium citrate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-6001-1 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 16, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
- Tamper Evident
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Directions
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 g Carton
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INGREDIENTS AND APPEARANCE
PLEO ALKALA ANTACID
sodium bicarbonate, potassium bicarbonate and sodium citrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-6001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium bicarbonate (UNII: 8MDF5V39QO) (sodium cation - UNII:LYR4M0NH37) sodium bicarbonate 11.70 g in 150 g potassium bicarbonate (UNII: HM5Z15LEBN) (potassium cation - UNII:295O53K152) potassium bicarbonate 117 g in 150 g sodium citrate (UNII: 1Q73Q2JULR) (sodium cation - UNII:LYR4M0NH37) sodium citrate 2.4 g in 150 g Inactive Ingredients Ingredient Name Strength calcium lactate (UNII: 2URQ2N32W3) sea salt (UNII: 87GE52P74G) sodium sulfate (UNII: 0YPR65R21J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-6001-1 1 in 1 CARTON 1 150 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/19/1996 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
