4624 - Rugby

4624 - Rugby
SPL v2
SPL
SPL Set ID bba7d5bf-c94b-4ee4-a399-9a2818d84c78
Route
ORAL
Published
Effective Date 2022-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (650 mg)
Inactive Ingredients
Croscarmellose Sodium Cellulose, Microcrystalline Stearic Acid Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: CPC77 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-25

Description

Active ingredient ( in each tablet) Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Active ingredient ( in each tablet) Sodium bicarbonate 10 gr (650 mg)

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 34088-5

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

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50568-5

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

Antacids may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you havea sodium restricted diet.

Section 53414-9

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

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.

Drug Facts

Active ingredient ( in each tablet)

Sodium bicarbonate 10 gr (650 mg)

​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

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:

Count 650 mg
60 71610-669-53
90 71610-669-60
180 71610-669-80

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



20221018JK

Principal Display Panel 650 Mg

NDC 71610-669 - Sodium Bicarbonate 650 mg Tablets


Structured Label Content

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

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

Antacids may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you havea sodium restricted diet.

Section 53414-9 (53414-9)

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

Purpose

Antacid

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.

Drug Facts

Active ingredient ( in each tablet)

Sodium bicarbonate 10 gr (650 mg)

​directions (​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 (Other information)
  • each tablet contains: sodium 178 mg
  • store at room temperature 15º - 30º C (59º - 86º F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-645-2158

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:

Count 650 mg
60 71610-669-53
90 71610-669-60
180 71610-669-80

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



20221018JK

Principal Display Panel 650 Mg (PRINCIPAL DISPLAY PANEL - 650 mg)

NDC 71610-669 - Sodium Bicarbonate 650 mg Tablets


Advanced Ingredient Data


Raw Label Data

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