h-e-b®

h-e-b®
SPL v4
SPL
SPL Set ID b70d4176-8bc1-4863-82df-90ae8391e4a2
Route
oral
Published
Effective Date 2019-06-18
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 sucralose sucrose water xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2019-05-14

Purpose

Anti-diarrheal/Upset stomach reliever

Description

Drug Facts


Medication Information

Uses

relieves

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink
  • heartburn
  • indigestion
  • nausea
  • gas
Purpose

Anti-diarrheal/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
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

Description

Drug Facts

Principal Display Panel

H-E-B®

NDC 37808-173-12

Compare to Kaopectate® active ingredient*

Diarrhea Relief

Bismuth Subsalicylate, 262 mg per 15 mL/

Antidiarrheal/Upset Stomach Reliever

Multi-Symptom Relief

Relief of 7 Types of Stomach Ailments

Vanilla Flavor

Contains Salicylates

12 FL OZ (355 mL)

MADE WITH PRIDE & CARE FOR H-E-B® SAN ANTONIA, TX 78204

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

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 product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

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

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

Ask a doctor before use if you have

  • a sodium-restricted diet
  • fever
  • mucus in the stool
Section 50570-1

Do not use if you 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

Anti-diarrheal/Upset stomach reliever

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.

Questions Or Comments?

1-866-467-2748

Active Ingredient (per 15 Ml)

Bismuth Subsalicylate 262 mg

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
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
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

Principal Display Panel

H-E-B®

NDC 37808-173-12

Compare to Kaopectate® active ingredient*

Diarrhea Relief

Bismuth Subsalicylate, 262 mg per 15 mL/

Antidiarrheal/Upset Stomach Reliever

Multi-Symptom Relief

Relief of 7 Types of Stomach Ailments

Vanilla Flavor

Contains Salicylates

12 FL OZ (355 mL)

MADE WITH PRIDE & CARE FOR H-E-B® SAN ANTONIA, TX 78204

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

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 product a 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 are taking any drug for

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

Ask a doctor before use if you have

  • a sodium-restricted diet
  • fever
  • mucus in the stool
Section 50570-1 (50570-1)

Do not use if you 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

Anti-diarrheal/Upset stomach reliever

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.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Active Ingredient (per 15 Ml) (Active Ingredient (per 15 mL))

Bismuth Subsalicylate 262 mg

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)