Label: BISMUTH SUBSALICYLATE- sunmark stomach relief tablet, chewable
- NDC Code(s): 68071-4523-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 49348-953
- 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 February 7, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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
Ask a doctor or pharmacist before use if you are
- taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
- allergic to salicylates (including aspirin)
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISMUTH SUBSALICYLATE
sunmark stomach relief tablet, chewableProduct 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)