SODIUM BICARBONATE - sodium bicarbonate tablet 
Aphena Pharma Solutions - Tennessee, LLC

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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Sodium Bicarbonate 10 gr Tablets, USP
Antacid

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

Drug Facts
Active ingredients (in each tablet)

Sodium Bicarbonate 10 gr (650mg)

Purpose
Antacid

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

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

Directions

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

Questions? 1-866-562-4597

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:

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN 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:

Count10 gr
6071610-438-53
9071610-438-60
12071610-438-70
18071610-438-80
36071610-438-94

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:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20200706JH

PRINCIPAL DISPLAY PANEL - 10 gr

NDC 71610-438 - Sodium Bicarbonate 10 gr Tablets
Bottle Label 10 gr

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-438(NDC:64980-294)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 294;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-438-5360 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
2NDC:71610-438-6090 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
3NDC:71610-438-80180 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
4NDC:71610-438-94360 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33102/01/2017
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-438)

Revised: 7/2020
Document Id: 8c2fd216-d341-4bfb-a25b-6e04602d34bb
Set id: f7ebb41a-d483-442a-95a0-47706cf3ee9a
Version: 1
Effective Time: 20200706
 
Aphena Pharma Solutions - Tennessee, LLC