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

Purpose

Upset stomach reliever and anti-diarrheal

Description

Drug Facts


Medication Information

Uses

relieves

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

Description

Drug Facts

Questions?

1-866-467-2748

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.

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.

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
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
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.

Questions?

1-866-467-2748

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.

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.

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

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