TOPCARE STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate suspension

TopCare Stomach Relief by

Drug Labeling and Warnings

TopCare Stomach Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL dose)

Bismuth subsalicylate 525 mg

Purposes

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 or 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 at (1-800-222-1222).

Directions

• ▪ shake well before use
• ▪ Only use dose cup provided
• ▪ adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
• ▪ 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• ▪ do not exceed 8 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 15 mL contains: sodium 10 mg
• salicylate 230 mg
• low sodium
• sugar free
• store at room temperature
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-888-423-0139

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.

Principal Display Panel

TopCare® health™

COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Stomach Relief

Bismuth Subsalicylate 1050 mg per 30 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYSMPTOM DIGESTIVE RELIEF

• Heartburn
• Indigestion
• Upset Stomach
• Nausea
• Diarrhea

OUR PHARMACISTS RECOMMEND

QUALITY GURANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 6007

TOPCO RARA0918

QUESTIONS? 1-888-423-0139

topcare@topco.com, www.topcarebrand.com

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol®.

Package Label 354 mL

Package Label 236 mL

INGREDIENTS AND APPEARANCE

TOPCARE STOMACH RELIEF  ULTRA STRENGTH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-341
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	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-341-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2019
2	NDC: 36800-341-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/14/2019

Labeler - TOPCO ASSOCIATES LLC (006935977)