Label: ESTOMAROL- aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate powder
Contains inactivated NDC Code(s)
NDC Code(s): 57465-100-00
- Packager: Laboratorios Imperiales, S.A. de C.V.
- 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.
Updated December 24, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
When using this product
- Do not take more than 6 doses in 24-hour period, or use more than 2 weeks, except under the advice and supervision of a physician.
- Do not use this product except under the advice and supervision of a physician if you have kidney disease or are on a sodium restricted diet.
- Do not take this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.
- Do not use if you are pregnant or lactating.
- Use caution in patients who are taking anticoagulants or who are diabetic.
- Do not administer to adolescents who have or have recently had chicken pox
- This medication can cause constipation and in large doses can cause diarrhea, dark urine and dark bowel movements.
- Do not give to children under 6
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
aluminum hydroxide, bismuth subcarbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57465-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 0.18 g in 3.5 g BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBCARBONATE 0.21 g in 3.5 g CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 0.25 g in 3.5 g MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 0.59 g in 3.5 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 2.27 g in 3.5 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57465-100-00 15 in 1 BOX 05/11/2011 1 3.5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 05/11/2011 Labeler - Laboratorios Imperiales, S.A. de C.V. (812643138) Establishment Name Address ID/FEI Business Operations Laboratorios Imperiales, S.A. de C.V. 812643138 manufacture(57465-100)