STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Shield Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

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

Warnings

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.
Allergy alert:Contains salicylate. Do not take if you are
allergic to salicylates (including aspirin)
taking other salicylate products

DO NOT USE

Do not use if you have
an ulcer
a bleeding problem
bloody or black stool

ASK DOCTOR

Ask a doctor before use if you have
fever
mucus in the stool

ASK DOCTOR/PHARMACIST

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

any drug for
anticoagulation (thinning the blood)
diabetes 
gout
arthritis

WHEN USING

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

swallow with water, do not chew
adults and children 12 years and over:
2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
do not exceed 8 doses (16 softgels) 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 softgel contains: salicylate 99 mg
very low sodium
store between 20-25° C (68-77° F)

Questions or comments?

1-800-373-6981 (toll-free)

Inactive ingredients

FD&C red #33, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 80, povidone, sorbitan, titanium dioxide

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

PRINCIPAL DISPLAY PANEL

ValuRx

Compare to the active ingredient in Pepto-Bismol® LiquicapsTM†

Stomach Relief
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
Soothing Relieves of 5 Symptoms:
Nausea
Heartburn
Indigestion
Upset Stomach
Diarrhea

Carton

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H)	BISMUTH	262 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	SD30
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0026-8	1 in 1 CARTON	04/07/2024
1		8 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	04/07/2024

Labeler - Shield Pharmaceuticals Corp (118724924)