5-SYMPTOM DIGESTIVE RELIEF- bismuth subsalicylate tablet

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Bismuth subsalicylate 262 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 (1-800-222-1222).

Directions

• swallow with water, do not chew
• adults and children 12 years and over:

-2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
-2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 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 27 mg
• salicylate 99 mg
• low sodium
• store at room temperature

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, silicon dioxide, sodium starch glycolate

Questions or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5-SYMPTOM DIGESTIVE RELIEF 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-880
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	262 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CALCIUM CARBONATE (UNII: H0G9379FGK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	127
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-880-44	1 in 1 CARTON	06/15/2024
1		40 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	06/15/2024

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(11673-880)