OTC Medication Information: Ultra Strength Digestive Relief

ULTRA STRENGTH DIGESTIVE RELIEF- bismuth subsalicylate tablet
THE KROGER CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each caplet)

Bismuth Subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

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 if you have

an ulcer
a bleeding problem
bloody or black stool

Ask a doctor before use if you have

fever
mucus in the stool

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

anticoagulation (thinning the blood)
diabetes
gout
arthritis

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

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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
store at room temperature

Inactive ingredients

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

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL — 24 Caplet Carton

NDC 30142-138-24

Ultra Strength

Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal

Symptom Digestive Relief

Heartburn
Indigestion
Nausea
Upset Stomach
Diarrhea

24 Caplets

2X STRENGTH per caplet*

Ultra Strength Digestive Relief 24 Caplets
(click image for full-size original)
ULTRA STRENGTH DIGESTIVE RELIEF
bismuth subsalicylate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-138
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 525 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSPOVIDONE (120 .MU.M)
D&C RED NO. 27
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
Product Characteristics
Color PINK Score no score
Shape OVAL (Caplet) Size 18mm
Flavor Imprint Code RP130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-138-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-138-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 11/18/2019
Labeler — THE KROGER CO. (006999528)

Revised: 06/2022 THE KROGER CO.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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