4621 - Rugby

4621 - Rugby
SPL v5
SPL
SPL Set ID e73b5871-4a87-4473-ab00-5e5395be017d
Route
ORAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (325 mg)
Inactive Ingredients
Croscarmellose Sodium Cellulose, Microcrystalline Stearic Acid Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: CPC76 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-25

Description

Active ingredient (in each tablet) Sodium bicarbonate 5 gr (325 mg)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Active ingredient (in each tablet) Sodium bicarbonate 5 gr (325 mg)

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5

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

WARNING: This product can expose you to chemicals including lead and mercury which are known to the State of

California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

DISTRIBUTED BY:

RUGBY® LABORATORIES

INDIANAPOLIS, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Rev. 10/23 R-29

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms last more than 2 weeks

Section 50568-5

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

Antacids may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you have a sodium restricted diet

Section 51945-4

Rugby

NDC 0536-1046-10

Sodium Bicarbonate 5 gr (325 mg)

ANTACID

1000 WHITE TABLETS

Section 53414-9

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

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

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 5 gr (325 mg)

Other Information
  • each tablet contains: sodium 89 mg
  • Store in a dry place at 15º - 30ºC (59º - 86º F)
Inactive Ingredients

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

Questions Or Comments?

1-800-231-4670


Structured Label Content

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5 (42229-5)

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

WARNING: This product can expose you to chemicals including lead and mercury which are known to the State of

California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

DISTRIBUTED BY:

RUGBY® LABORATORIES

INDIANAPOLIS, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Rev. 10/23 R-29

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms last more than 2 weeks

Section 50568-5 (50568-5)

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

Antacids may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a sodium restricted diet

Section 51945-4 (51945-4)

Rugby

NDC 0536-1046-10

Sodium Bicarbonate 5 gr (325 mg)

ANTACID

1000 WHITE TABLETS

Section 53414-9 (53414-9)

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

Purpose

Antacid

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

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 5 gr (325 mg)

Other Information (Other information)
  • each tablet contains: sodium 89 mg
  • Store in a dry place at 15º - 30ºC (59º - 86º F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-231-4670


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)