SODIUM BICARBONATE- sodium bicarbonate powder 
Humco Holding Group, Inc.

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.

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Private Label Sodium Bicarbonate


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

Premier Value Label

4 oz

PV 4

16 oz

PV 16

Vida Mia Label

VM

Medis Label

Medis NaBicarb.jpg

SODIUM BICARBONATE 
sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1000 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9124-01454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2017
2NDC:0395-9124-94113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/27/2017
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884label(0395-9124) , manufacture(0395-9124) , pack(0395-9124) , analysis(0395-9124)

Revised: 6/2020
Document Id: a8859347-4b3b-5572-e053-2a95a90a1e8f
Set id: 606524be-6896-dd7a-e053-2991aa0a228e
Version: 3
Effective Time: 20200620
 
Humco Holding Group, Inc.