Label: 5-SYMPTOM DIGESTIVE RELIEF- bismuth subsalicylate tablet
- NDC Code(s): 11673-880-44
- Packager: TARGET CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 26, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- 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 the blood)
- diabetes
- gout
- arthritis
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Directions
- swallow with water, do not chew
- adults and children 12 years and over:
-2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
-2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)- do not exceed 8 doses (16 caplets) 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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
5-SYMPTOM DIGESTIVE RELIEF
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-880 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 262 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) MANNITOL (UNII: 3OWL53L36A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MAGNESIUM STEARATE (UNII: 70097M6I30) CALCIUM CARBONATE (UNII: H0G9379FGK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color pink Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-880-44 1 in 1 CARTON 06/15/2024 1 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 06/15/2024 Labeler - TARGET CORPORATION (006961700) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(11673-880)