Label: 5 SYMPTOM DIGESTIVE RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 11673-723-48
- Packager: TARGET CORPORATION
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- chew or dissolve in mouth
- adults and children 12 years and over:
-2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
-2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 tablets) 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
5 SYMPTOM DIGESTIVE RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-723 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 SACCHARIN SODIUM (UNII: SB8ZUX40TY) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) CALCIUM CARBONATE (UNII: H0G9379FGK) TALC (UNII: 7SEV7J4R1U) MANNITOL (UNII: 3OWL53L36A) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color pink (Light pink to pink) Score no score Shape ROUND Size 15mm Flavor Imprint Code 118 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-723-48 8 in 1 CARTON 06/15/2024 1 6 in 1 CELLO PACK; 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 MARKSANS PHARMA LIMITED 925822975 manufacture(11673-723)