Label: GOODSENSE MAXIMUM STRENGTH STOMACH RELIEF 528- bismuth subsalicylate liquid
- NDC Code(s): 50804-154-04
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 17, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each 30 mL)
- PURPOSE
- USE(S)
-
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.
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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
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- shake well before use
- mL = milliliter
- TBSP = tablespoon
- adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every hour as needed
- do not exceed 4 doses (8 TBSP or 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 fluids to help prevent dehydration caused by diarrhea
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOODSENSE MAXIMUM STRENGTH STOMACH RELIEF 528
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-154 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) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-154-04 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 09/13/2024 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(50804-154)
