Search by Drug Name or NDC

NDC 54638-0004-01 Rehydrate Jr. 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL Details

Rehydrate Jr. 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL

Rehydrate Jr. is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by ParaDocs All Natural, Inc.. The primary component is ADENOSINE TRIPHOSPHATE DISODIUM; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA ROOT; ULMUS RUBRA BARK; WATER.

Product Information

NDC	54638-0004
Product ID	54638-0004_6aebf3a4-cc32-47ec-8d67-dbdf401fb313
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Rehydrate Jr.
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Glycyrrhiza Glabra, Pueraria Lobata, Aqua Sulis, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygenium, Wiesbaden
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12
Active Ingredient Units	[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
Substance Name	ADENOSINE TRIPHOSPHATE DISODIUM; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA ROOT; ULMUS RUBRA BARK; WATER
Labeler Name	ParaDocs All Natural, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54638-0004-01 (54638000401)

Pricing Information	N/A
NDC Package Code	54638-0004-1
Billing NDC	54638000401
Package	60 mL in 1 BOTTLE, DROPPER (54638-0004-1)
Marketing Start Date	2020-03-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7b26617e-480d-4bc5-bbc5-019077885658 Details

ACTIVE INGREDIENTS:

Avena Sativa 3X, Equisetum Hyemale 4X, Hypericum Perforatum 6X, Ulmus Fulva 6X, Glycyrrhiza Glabra 12X, Pueraria Lobata 12X, Aqua Sulis 12C, Carlsbad Aqua 12C, Adenosinum Triphosphoricum Dinatrum 30C, Germanium Sesquioxide 30C, Hydrogen 3C, Oxygenium 30C, Wiesbaden 30C.

INDICATIONS:

To aid with proper hydration.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

One drop per ounce of pure water. Consult a physician for use in children under 6 years of age.

INDICATIONS:

To aid with proper hydration.

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 1%, Glycerin, Proprietary Extract Blend of Beet (Root), Blessed Thistle (Aerial Parts), Boldo (Leaf), Celandine (Aerial Parts), Dandelion (Root), Parsley (Leaf).

QUESTIONS:

MFD. FOR:

ParaDocs All Natural Inc.

2640 E. Oakland Park Blvd.

Ft. Lauderdale, FL 33306

PACKAGE LABEL DISPLAY:

ReHydrateJr.

Homeopathic

2 FL OZ (60 ml)

INGREDIENTS AND APPEARANCE

REHYDRATE JR.

avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, glycyrrhiza glabra, pueraria lobata, aqua sulis, carlsbad aqua, adenosinum triphosphoricum dinatrum, germanium sesquioxide, hydrogen, oxygenium, wiesbaden liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54638-0004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X] in 1 mL
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	4 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 1 mL
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q)	ULMUS RUBRA BARK	6 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	12 [hp_X] in 1 mL
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) (PUERARIA MONTANA VAR. LOBATA ROOT - UNII:PET93F4I3C)	PUERARIA MONTANA VAR. LOBATA ROOT	12 [hp_X] in 1 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	12 [hp_C] in 1 mL
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE DISODIUM	30 [hp_C] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	30 [hp_C] in 1 mL
HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z)	HYDROGEN	30 [hp_C] in 1 mL
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BEET (UNII: N487KM8COK)
CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
CHELIDONIUM MAJUS FLOWERING TOP (UNII: O9HP59XU7F)
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
PARSLEY (UNII: 58FMD0Q0EV)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54638-0004-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/11/2020

Labeler - ParaDocs All Natural, Inc. (008540744)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(54638-0004) , api manufacture(54638-0004) , label(54638-0004) , pack(54638-0004)

Revised: 3/2020

Document Id: 6aebf3a4-cc32-47ec-8d67-dbdf401fb313

Set id: 7b26617e-480d-4bc5-bbc5-019077885658

Version: 1

Effective Time: 20200311

Search by Drug Name or NDC

NDC 54638-0004-01 Rehydrate Jr. 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL Details

Rehydrate Jr. 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL

Product Information

Package

Package Images

NDC 54638-0004-01 (54638000401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7b26617e-480d-4bc5-bbc5-019077885658 Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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