SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet

Sodium Bicarbonate Antacid by

Drug Labeling and Warnings

Sodium Bicarbonate Antacid by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 5 gr (325 mg)

Purpose

Antacid

Uses

relieves

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms

Warnings

Warnings

Ask a doctor or pharmacist before use of 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.

This package for households without young children. This package is intended for in-patient institutional use only. This package is not child resistant.

Each tablet contains: sodium 89 mg

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.

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: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
• adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

Other information

• each tablet contains: sodium 89 mg
• store at room temperature 15º - 30ºC (59º - 86º F)

Inactive ingredients

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid, and talc

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

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

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 293

Livonia, MI 48152

www.rugbylaboratories.com

Rev. 11/16 R-29

PRINCIPAL DISPLAY PANEL

Rugby

NDC: 0536-1046-10

Sodium Bicarbonate 5 gr (325 mg)

ANTACID

1000 WHITE TABLETS

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE ANTACID 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	325 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC76
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1046-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/25/2015

Labeler - Rugby Laboratories (079246066)