SUEROLYTE ORAL ELECTROLYTE SOLUTION STRAWBERRY BANANA FLAVOR- dextrose, citric acid, potassium citrate, sodium chloride,sodium citrate, sucralose, acesulfame potassium, zinc gluconate, potassium sorbate liquid

SUEROLYTE Oral Electrolyte Solution Strawberry Banana Flavor by

Drug Labeling and Warnings

SUEROLYTE Oral Electrolyte Solution Strawberry Banana Flavor by is a Other medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, Alfa Vitamins Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Dietary Supplement1

1 This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure or prevent any disease.

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

Distributed by

Essential Products Miami FL 33126

www.essentialproductsuse.com

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUEROLYTE ORAL ELECTROLYTE SOLUTION STRAWBERRY BANANA FLAVOR 
dextrose, citric acid, potassium citrate, sodium chloride,sodium citrate, sucralose, acesulfame potassium, zinc gluconate, potassium sorbate liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:70242-112
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)
STRAWBERRY (UNII: 4J2TY8Y81V)
BANANA (UNII: 4AJZ4765R9)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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:70242-112-33	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

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(70242-112)

Establishment
Name	Address	ID/FEI	Business Operations
Alfa Vitamins Laboratories Inc		079327988	MANUFACTURE(70242-112)