Label: PLEO CITRO- citric acid monohydrate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-8003-1 - Packager: Sanum-Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 26, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- Indications
- ACTIVE INGREDIENT
- Tamper Evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Blister Pack Carton
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INGREDIENTS AND APPEARANCE
PLEO CITRO
citric acid monohydrate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-8003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) CITRIC ACID MONOHYDRATE 200 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) STARCH, POTATO (UNII: 8I089SAH3T) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-8003-1 8 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 07/10/2012 Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133) Establishment Name Address ID/FEI Business Operations Sanum-Kehlbeck GmbH & Co. KG 318386133 MANUFACTURE(60681-8003)