Label: MEDIS SODIUM BICARBONATE- sodium bicarbonate powder
- NDC Code(s): 0802-2685-94
- Packager: Humco Holding Group, Inc
- 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 November 10, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Soduim Bicarbonate, USPClose
For relief of heartburn, acid indigestion, and upset stomach associated with these symptoms.Close
- Warnings NOT FOR INJECTIONS
Except under supervision of a doctor do not administer to children under 6 years of age.
Do not take more than six, 1/2 tsp. per person up to 60 years old, or three 1/2 tsp. per person 60 years or older in a 24 hour period.
Do not use this product if you are on a sodium restricted diet (each 1/2 tsp. contains 30 mEq (0.7 g) Sodium).
Do not use the maximum does more than 2 weeks.Close
- Ask a doctor or pharmacist before use if
you are currently taking a prescription drug. Antacids may interact with certain prescription drugs.Close
- Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.Close
Adult and children 6 yrs of age and older:
Take 1/2 tsp. in 1/2 g;ass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by doctor.Close
- Inactive ingredients
- INGREDIENTS AND APPEARANCE
MEDIS SODIUM BICARBONATE
sodium bicarbonate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0802-2685 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1000 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0802-2685-94 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/09/2017 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/09/2017 04/30/2020 Labeler - Humco Holding Group, Inc (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 label(0802-2685) , manufacture(0802-2685) , pack(0802-2685) , analysis(0802-2685)