KAOPECTATE- bismuth subsalicylate liquid

Kaopectate by

Drug Labeling and Warnings

Kaopectate by is a Otc medication manufactured, distributed, or labeled by KRAMER LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (per 15 mL)

Bismuth subsalicylate 525 mg

Purposes

Anti-diarrheal
Upset stomach reliever

Uses

relieves:

• traveler's 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

• a sodium-restricted diet
• fever
• mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

• diabetes
• gout
• arthritis
• anticoagulation (thinning the blood)

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
• 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

• shake well immediately before each use
• only use pre-measured dose cup
• adults and children 12 years of age and older: 1 dose (30 mL) every hour as needed.
• do not exceed 4 doses (120 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 information

• each 30 mL dose cup contains: sodium 13 mg and salicylate 507 mg
• store at room temperature 20°-25° C (68°-77° F)

Inactive ingredients

caramel, carboxymethylcellulose sodium, FD&C Red No. 40, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum

Principal Display Panel

EXTRA
STRENGTH

2X
THE MEDICINE
PER DOSE

Kaopectate®
Bismuth Subsalicylate 525 mg
● Anti-Diarrheal ● Upset stomach Reliever

Diarrhea &
Upset Stomach

√ Begins controlling symptoms from the first dose
√ Twice the medicine as regular strength Kaopectate
√ Quickly relieves urgency, gas, and cramping

11 fl oz (325 mL)

Peppermint Flavor

682PPT11KA0LB

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING
Kramer Laboratories, Bridgewater, NJ 08807 1-800-824-4894
K0825        682PPT11KA0LB

Lot:

Exp:

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DRUG FACTS AND INFORMATION

INGREDIENTS AND APPEARANCE

KAOPECTATE 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-229
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 15 mL

Inactive Ingredients
Ingredient Name	Strength
Caramel (UNII: T9D99G2B1R)
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sodium Salicylate (UNII: WIQ1H85SYP)
Sorbic Acid (UNII: X045WJ989B)
Sucrose (UNII: C151H8M554)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-229-64	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	02/01/2026

Labeler - KRAMER LABORATORIES (122720675)