RITE AID ULTRA STRNGHT PINK BISMUTH- bismuth subsalicylate suspension

RITE AID Ultra Strnght by

Drug Labeling and Warnings

RITE AID Ultra Strnght by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION. 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 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 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) every1/2 hour or 30 mL (2 doses) every hours as needed for diarrhea/traveler’s diarrhea
• 15 mL (1dose) every ½ 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 (more than 104°F or 40°C).

Inactive ingredients

carboxymethylcellulose sodium, D&C Red #22, D&C Red #28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength *

Ultra-Strength

Pink Bismuth

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Original flavor

Relieves:

• ▪ Nausea
• ▪ Heartburn
• ▪ Indigestion
• ▪ Upset Stomach
• ▪ Diarrhea

12FL. OZ. (354 mL)

Distributed By:

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

Package Label 354 mL

Package Label 236 mL

INGREDIENTS AND APPEARANCE

RITE AID ULTRA STRNGHT  PINK BISMUTH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7070
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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, UNSPECIFIED (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: 11822-7070-2	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2023
2	NDC: 11822-7070-8	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	01/02/2023

Labeler - RITE AID CORPORATION (014578892)