NDC | 51596-004-01, 51596-004-05, 51596-004-10, 51596-004-12, 51596-004-24 |
Set ID | a019eedf-073d-43c6-ad30-dedb9dd51fbd |
Category | HUMAN OTC DRUG LABEL |
Packager | Breakthrough Products Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART335 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (per powder)
- Purpose
- Uses
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Warnings
Reye's syndrome
Children and teenagers who have or are recovering from chickenpox 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.
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
adults and children 12 years and over:
- see instructions in red box for opening packet
- place 1 powder on the tongue and swallow with or without water every ½ to 1 hour as needed
- do not exceed 8 doses in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 Powder Packet
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INGREDIENTS AND APPEARANCE
UPSET STOMACH RELIEF TO GO
bismuth subsalicylate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-004 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 525 mg Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) dextrose (UNII: IY9XDZ35W2) silicon dioxide (UNII: ETJ7Z6XBU4) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51596-004-05 5 in 1 BOX 1 NDC:51596-004-01 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:51596-004-12 12 in 1 BOX 2 NDC:51596-004-01 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:51596-004-24 24 in 1 BOX 3 NDC:51596-004-01 1 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:51596-004-10 10 in 1 BOX 4 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 09/01/2011 Labeler - Breakthrough Products Inc. (962008251)