MEDIS SODIUM BICARBONATE- sodium bicarbonate powder

Medis Sodium Bicarbonate by

Drug Labeling and Warnings

Medis Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Soduim Bicarbonate, USP

Purpose

Antacid

Use

For relief of heartburn, acid indigestion, and upset stomach associated with these symptoms.

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.

Ask a doctor or pharmacist before use if

you are currently taking a prescription drug. Antacids may interact with certain prescription drugs.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

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.

Inactive ingredients

none

Label

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)