BISMUTH SUBSALICYLATE- sunmark stomach relief tablet, chewable

Bismuth subsalicylate by

Drug Labeling and Warnings

Bismuth subsalicylate by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal

KEEP OUT OF REACH OF CHILDREN

Uses

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms
  

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

• bloody or black stools
• an ulcer
• a bleeding problem
  

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 of 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
• 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 immediately.

Directions

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) in 24 hours
• children under 12 years: ask a doctor
• drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Other information

each tablet contains:

• Sodium less than 1 mg
• salicylate 102 mg
• very low sodium
• avoid excessive heat (over 104˚F or 40˚C)
• TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

INGREDIENTS AND APPEARANCE

BISMUTH SUBSALICYLATE 
sunmark stomach relief tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-4523(NDC:49348-953)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	GDC122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-4523-3	30 in 1 BOX; Type 0: Not a Combination Product	08/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/01/2011

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4523)