| NDC | 70242-115-33 |
| Set ID | e9c12a06-ff12-4617-9bb8-037569667695 |
| Category | DIETARY SUPPLEMENT |
| Packager | Dannso Corp./d.b.a. Essential Products |
| Generic Name | |
| Product Class | Anti-coagulant |
| Product Number | |
| Application Number |
- STATEMENT OF IDENTITY
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WARNINGS
Warnings
Do not use if neckband is broken or missing. Do not use if inner seal is broken or missing.
Ready to use. Do not add water. Store in a cool place. If experirncing vomitting, fever, or diarrhea continues beyond 24 hours, consult your physician.
Pregnancy / Breastfeeding: If pregnant or breastfeeding, ask a health professional before use. -
DOSAGE & ADMINISTRATION
Directions
Children 1 year of age and older: offer solution every 15 minutes. The child should take from 1 to 2 liters per day while diarrhea continues.
Adults: can drink 1 to 2 fl. oz. every half hour, increasing the amount slowly. Reseal bottle with original cap.
Refrigerate and use within 48 hours.
Do not reuse container. Children under 1 year of age: consults physician before using. - Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUEROLYTE ORAL ELECTROLYTE SOLUTION ORANGE FLAVOR
dextrose, citric acid, potassium citrate, sodium chloride,sodium citrate, sucralose, acesulfame potassium, zinc gluconate, potassium sorbate liquidProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70242-115 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 25 g in 1 L POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE 20 meq in 1 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 45 meq in 1 L SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6) SODIUM CHLORITE 35 meq in 1 L ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 35 meq in 1 L Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Citric Acid MONOHYDRATE (UNII: 2968PHW8QP) ORANGE (UNII: 5EVU04N5QU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Sodium Citrate, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Sucralose (UNII: 96K6UQ3ZD4) Acesulfame Potassium (UNII: 23OV73Q5G9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70242-115-33 1 L in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 08/07/2015 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value flavor Labeler - Dannso Corp./d.b.a. Essential Products (059741071) Registrant - Dannso Corp./d.b.a. Essential Products (059741071) Establishment Name Address ID/FEI Business Operations Dannso Corp./d.b.a. Essential Products 059741071 LABEL(70242-115) Establishment Name Address ID/FEI Business Operations Alfa Vitamins Laboratories Inc 079327988 MANUFACTURE(70242-115)
