Ultra Strength Digestive Relief 24 Caplets

Ultra Strength Digestive Relief 24 Caplets
SPL v4
SPL
SPL Set ID 756e7a47-7e14-4694-84fa-ca6396f7edcc
Route
ORAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Calcium Carbonate Crospovidone (120 .mu.m) D&c Red No. 27 Magnesium Stearate Microcrystalline Cellulose Polysorbate 80 Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: RP130 Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

Description

Drug Facts

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Drug Facts

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Section 50566-9

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Section 50567-7

When using this producta temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1

Do not use ifyou have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 53414-9

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

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over:1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (8 caplets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Questions?

1-866-467-2748

Allergy Alert

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Reye's Syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Other Information
  • each caplet contains:calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • store at room temperature
Inactive Ingredients

calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate.

Active Ingredient (in Each Caplet)

Bismuth Subsalicylate 525 mg

Principal Display Panel 24 Caplet Carton

Compare to the active Ingredient in Pepto-Bismosol® Ultra Caplets*

NDC 0363-1302-02

Ultra Strength

Digestive Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

2X CONCENTRATED FORMULA

24 Caplets


Structured Label Content

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Section 50567-7 (50567-7)

When using this producta temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1 (50570-1)

Do not use ifyou have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over:1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (8 caplets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Questions?

1-866-467-2748

Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Reye's Syndrome (Reye's syndrome)

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Other Information (Other information)
  • each caplet contains:calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth Subsalicylate 525 mg

Principal Display Panel 24 Caplet Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Carton)

Compare to the active Ingredient in Pepto-Bismosol® Ultra Caplets*

NDC 0363-1302-02

Ultra Strength

Digestive Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

2X CONCENTRATED FORMULA

24 Caplets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)