Label: SUEROLYTE ORAL ELECTROLYTE SOLUTION LEMON-LIME FLAVOR- dextrose, citric acid, potassium citrate, sodium chloride,sodium citrate, sucralose, acesulfame potassium, zinc gluconate, potassium sorbate liquid
- NHRIC Code(s): 70242-114-33
- Packager: Dannso Corp./d.b.a. Essential Products
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 14, 2015
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- 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 LEMON-LIME 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:70242-114 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) LEMON (UNII: 24RS0A988O) 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:70242-114-33 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(70242-114) Establishment Name Address ID/FEI Business Operations Alfa Vitamins Laboratories Inc 079327988 MANUFACTURE(70242-114)
