BISMUTH SUBSALICYLATE 262 MG- bismuth subsalicylate tablet, chewable

Bismuth Subsalicylate 262 mg by

Drug Labeling and Warnings

Bismuth Subsalicylate 262 mg by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Anti-diarrheal / Upset stomach reliever

Uses

• controls diarrhea
• relieves upset stomach due to overindulgence in food or drink

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Contains salicylates. Do not take if you are:

• allergic to salicylates (including aspirin)
• taking other salicylate products

DO NOT USE

Do not use

• if you have bloody or black stool
• if you have an ulcer or bleeding problem

Drug Facts continued on back of label

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.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• repeat dosage every 1/2 to 1 hour as needed
• do not take more than 8 doses in 24 hours
• use until diarrhea stops but not more than 2 days
• adults and children 12 years and over: 2 tablets
• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 77 mg, salicylate 102 mg
• store at 15°-30°C (59°-86°F)
• protect from moisture

Inactive ingredients

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 69618-029-03

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

INGREDIENTS AND APPEARANCE

BISMUTH SUBSALICYLATE 262 MG 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-029
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTROSE (UNII: IY9XDZ35W2)
CHERRY (UNII: BUC5I9595W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-029-03	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)