SODIUM BICARBONATE- sodium bicarbonate tablet, orally disintegrating

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

ACTIVE INGREDIENT

Drug Facts
Active ingredients (in each tablet)
Sodium Bicarbonate 10 gr (650mg)

PURPOSE

Purpose
Antacid

INDICATIONS & USAGE

Uses: relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms

WARNINGS

Warnings
Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Ask a doctor before use if you have a sodium restricted diet.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• do not use the maximum dosage for more than 2 weeks
• tablets may be swallowed whole or dissolved in water prior to use
• adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
• adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

STORAGE AND HANDLING

Other Information:  Each tablet contains: sodium 178 mg (7.74 mEq) store at room temperature 15°-30°C (59°-86°F) in a well closed container as defined in the USP.

INACTIVE INGREDIENT

Inactive Ingredients:  Croscarmellose sodium NF, microcrystalline cellulose NF, silica NF, stearic acid NF and talc USP.

QUESTIONS

Questions? 1-866-562-4597

SPL UNCLASSIFIED SECTION

11790-11-16             REV 11/16

Manufactured for:                                 Manufactured by:
Rising Pharmaceuticals, Inc.                    Contract Pharmacal Corp.
Allendale, NJ 07401                                 Hauppauge, NY 11788

Lot No.:

Exp. Date:

HOW SUPPLIED

Product: 50090-3021

NDC: 50090-3021-0 90 TABLET, ORALLY DISINTEGRATING in a BOTTLE

sodium bicarbonate

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE  
sodium bicarbonate tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-3021(NDC:64980-294)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	650 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	294;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-3021-0	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/01/2017

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-3021) , REPACK(50090-3021)