5-SYMPTOM DIGESTIVE RELIEF- bismuth subsalicylate suspension

5-Symptom Digestive Relief by

Drug Labeling and Warnings

5-Symptom Digestive Relief by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

ACTIVE INGREDIENT

Active ingredient
(in each 30 mL dose)

Bismuth subsalicylate 525 mg

PURPOSE

Purpose

Upset stomach reliever and antidiarrheal

INDICATIONS & USAGE

Uses relieves

■ travelers’ diarrhea

■ diarrhea

■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

WARNINGS

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
■ 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 right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions
■ shake well before use
■ only use dose cup provided
■ adults and children 12 years and over:

- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea

- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
■ do not exceed 8 doses (240 mL) 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 SAFETY INFORMATION

Other information
■ each 30 mL dose contains: salicylate 199 mg
■ keep tightly closed ■ protect from freezing
■ avoid excessive heat (over 104°F or 40°C)

INACTIVE INGREDIENT

Inactive ingredients benzoic acid, D&C red no. 22, D&C red no. 28, flavor, glycerin, purified water, sucralose, xanthan gum

QUESTIONS

Questions or comments? Call 1-800-910-6874

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5-SYMPTOM DIGESTIVE RELIEF 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-291
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
D&C RED NO. 22 (UNII: 1678RKX8RT)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-291-06	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2025
2	NDC: 11673-291-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2025
3	NDC: 11673-291-08	2 in 1 PACKAGE	06/16/2025
3	NDC: 11673-291-07	473 mL in 1 BOTTLE, PLASTIC; 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	06/16/2025

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(11673-291)