Label: STOMACH RELIEF, ULTRA STRENGTH- bismuth subsalicylate suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 68998-558-28 - Packager: Marc Glassman, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions ■ Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose (30 mL or 2
TBSP) every 1 hour as needed
■ do not exceed 4 doses (120 mL or 8 TBSP) 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
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Marc's Product Label
NDC 68998-558-28 * Compare to the active
ingredients in Pepto-BismolTM
Maximum Strength
Marc's
ULTRA STRENGTH
Stomach Relief
Antidiarrheal / Upset Stomach Reliever
Bismuth subsalicylate5 Symptoms Relief of
• Nausea • Upset Stomach•
• Heartburn • Diarrhea
• Indigestion
12 FL OZ (354 mL)
TAMPER EVIDENT: Do not use if imprinted shrinkband is
missing or broken*Thls product is not manufactured or dlstnbuted by Procter & Gamble, Inc"
distributor of Pepto BismolTMDistributed by: LR-144
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130Lot.
Exp.res
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INGREDIENTS AND APPEARANCE
STOMACH RELIEF, ULTRA STRENGTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-558 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 1050 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color pink Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-558-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 12/15/2020 Labeler - Marc Glassman, Inc. (094487477)