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 Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

relieves:

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

Warnings

Do not takemore than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr 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 havea sodium restricted diet.

Ask a doctor or pharmacist before use if you aretaking a prescription drug.

Antacids may interact with certain prescription drugs.

Stop use and ask a doctor ifsymptoms last more than 2 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

​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

Other information

• each tablet contains: sodium 178 mg
• store at room temperature 15º - 30º C (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 233

Livonia, MI 48152

www.rugbylaboratories.com

Rev. 12/16 R-29

Repackaging Information

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

10gr (650mg)
NDC: 71610-669-53, Bottles of 60 Tablets
NDC: 71610-669-60, Bottles of 90 Tablets
NDC: 71610-669-80, Bottles of 180 Tablets

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20260323BSC

PRINCIPAL DISPLAY PANEL - 650 mg

NDC: 71610-669 - Sodium Bicarbonate 10gr (650 mg) Tablets

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE ANTACID 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-669(NDC:0536-1047)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	650 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	11mm
Flavor		Imprint Code	CPC77
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-669-53	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022
2	NDC: 71610-669-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022
3	NDC: 71610-669-80	180 in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	03/25/2015

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	repack(71610-669)