Quality Choice Diarrhea Relief Bismuth Subsalicylate Vanilla Regular Flavor

Quality Choice Diarrhea Relief Bismuth Subsalicylate Vanilla Regular Flavor
SPL v6
SPL
SPL Set ID 02737763-eb98-401d-942c-186c401a2d31
Route
ORAL
Published
Effective Date 2019-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Caramel Carboxymethylcellulose Sodium, Unspecified Microcrystalline Cellulose Potassium Sorbate Salicylic Acid Dimethicone, Unspecified Sucralose Sucrose Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-16

Description

Drug Facts

Purpose

Antidiarrheal/Upset stomach reliever


Medication Information

Purpose

Antidiarrheal/Upset stomach reliever

Description

Drug Facts

Uses

Relieves

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink
  • heartburn
  • indigestion
  • nausea
  • gas
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 right away at 1-800-222-1222.

Section 50566-9

Stop use and ask a doctor if

  • symptoms get worse
  • 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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)
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.

Purposes

Antidiarrheal/Upset stomach reliever

Directions
  • shake well immediately before each use
  • adults and children 12 years of age and older : 30 ml or 2 tablespoonful
  • for accurate dosing, use convenient pre-measured dose cup
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 doses 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
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 15mL tablespoon contains:sodium 10 mg
  • each 15mL tablespoon contains:salicylate 130 mg
  • do not use if printed inner seal is broken or missing
  • store at room temperature
Inactive Ingredients

caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

Questions Or Comments?

1-866-467-2748

Active Ingredient (per 15 Ml)

Bismuth subsalicylate 262 mg

Principal Display Panel 355 Ml Bottle Label

NDC 63868-339-12

Compare to the active ingredient in Kaopectate ®

Diarrhea Relief

Bismuth Subsalicylate, 262 mg

Bismuth Subsalicylate, 262 mg

Antidiarrheal

Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

  • Vanilla Regular Flavor

12 FL OZ (355 mL)

100% SATISFACTION GUARANTEED

Distributed by: C.D.M.A., Inc.

43157 W. Nine Mile

Novi. MI 48376-0995

www.qualitychoice.com

Question: 248-449-9300

*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

Allergy Alert: Contains Salicylate. Do Not Take If You Are
  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Structured Label Content

Uses

Relieves

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink
  • heartburn
  • indigestion
  • nausea
  • gas
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 right away at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms get worse
  • 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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)
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.

Purposes

Antidiarrheal/Upset stomach reliever

Directions
  • shake well immediately before each use
  • adults and children 12 years of age and older : 30 ml or 2 tablespoonful
  • for accurate dosing, use convenient pre-measured dose cup
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 doses 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
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 15mL tablespoon contains:sodium 10 mg
  • each 15mL tablespoon contains:salicylate 130 mg
  • do not use if printed inner seal is broken or missing
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Active Ingredient (per 15 Ml) (Active ingredient (per 15 ml))

Bismuth subsalicylate 262 mg

Principal Display Panel 355 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label)

NDC 63868-339-12

Compare to the active ingredient in Kaopectate ®

Diarrhea Relief

Bismuth Subsalicylate, 262 mg

Bismuth Subsalicylate, 262 mg

Antidiarrheal

Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

  • Vanilla Regular Flavor

12 FL OZ (355 mL)

100% SATISFACTION GUARANTEED

Distributed by: C.D.M.A., Inc.

43157 W. Nine Mile

Novi. MI 48376-0995

www.qualitychoice.com

Question: 248-449-9300

*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

Allergy Alert: Contains Salicylate. Do Not Take If You Are (Allergy alert: Contains salicylate. Do not take if you are)
  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)