4624 - Rugby

4624 - Rugby
SPL v6
SPL
SPL Set ID 28cdf049-acdb-4098-a5ca-e86257c81954
Route
ORAL
Published
Effective Date 2022-12-06
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, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5

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

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING

LEAD, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND

BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION

GO TO WWW.P65WARNINGS.CA.GOV.

Rev. 10/22 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 0536-1047-10

Sodium Bicarbonate 10 gr (650 mg)

ANTACID

1000 TABLETS

Section 53414-9

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

Warnings

Do not take more 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 in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid, 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 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5 (42229-5)

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

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING

LEAD, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND

BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION

GO TO WWW.P65WARNINGS.CA.GOV.

Rev. 10/22 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 0536-1047-10

Sodium Bicarbonate 10 gr (650 mg)

ANTACID

1000 TABLETS

Section 53414-9 (53414-9)

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

Purpose

Antacid

Warnings

Do not take more 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 in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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