Search by Drug Name or NDC

NDC 51987-0002-01 Hydrate 3; 2; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Hydrate 3; 2; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Hydrate is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Maplewood Company. The primary component is AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; SILICON DIOXIDE.

Product Information

NDC	51987-0002
Product ID	51987-0002_4632800b-a1d7-464f-bee3-d3d9ebbdb54d
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	Hydrate
Proprietary Name Suffix	II
Non-Proprietary Name	Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	3; 2; 3; 8; 6; 3; 8
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; SILICON DIOXIDE
Labeler Name	Maplewood Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51987-0002-01 (51987000201)

Pricing Information	N/A
NDC Package Code	51987-0002-1
Billing NDC	51987000201
Package	30 mL in 1 BOTTLE, DROPPER (51987-0002-1)
Marketing Start Date	2013-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 320c9fb7-9c3f-44a5-8c34-13266b036cca Details

ACTIVE INGREDIENTS:

Coffea Tosta 2X, Avena Sativa 3X, Equisetum Hyemale 3X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silicea 8X.

INDICATIONS:

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternating with diarrhea, chronic myalgia, headache and low back pain.

WARNINGS:

If pregnant or breast-feeding, ask a health care professinal 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.

DIRECTIONS:

Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz. mixture. Drink 4 eight oz glasses daily in between meals. Drink hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less hydrate/water mixture. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Celandine, Beet, Blessed Thistle, Boldo, Dandelion, Parsley, Demineralized Water, 25% Ethanol

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.

INDICATIONS:

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternating with diarrhea, chronic myalgia, headache and low back pain.

QUESTIONS:

Manufactured For:

Maplewood Company

7334 S. Alton Way

Building #14, Ste. A

Centennial, CO 80112

PACKAGE DISPLAY LABEL:

HYDRATE II

HOMEOPATHIC

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

HYDRATE II

coffea tosta, avena sativa, equisetum hyemale, hypericum perforatum, ginkgo biloba, germanium sesquioxide, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51987-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E)	COFFEA ARABICA SEED, ROASTED	2 [hp_X] in 1 mL
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	3 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	8 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CHELIDONIUM MAJUS (UNII: 7E889U5RNN)
BEET (UNII: N487KM8COK)
CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
TARAXACUM OFFICINALE (UNII: 39981FM375)
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51987-0002-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/22/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/22/2013

Labeler - Maplewood Company (022963389)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(51987-0002) , api manufacture(51987-0002) , label(51987-0002) , pack(51987-0002)

Revised: 11/2019

Document Id: 4632800b-a1d7-464f-bee3-d3d9ebbdb54d

Set id: 320c9fb7-9c3f-44a5-8c34-13266b036cca

Version: 3

Effective Time: 20191111

Search by Drug Name or NDC

NDC 51987-0002-01 Hydrate 3; 2; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Hydrate 3; 2; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 51987-0002-01 (51987000201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 320c9fb7-9c3f-44a5-8c34-13266b036cca Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

DIRECTIONS:

INACTIVE INGREDIENTS:

KEEP OUT OF REACH OF CHILDREN:

INDICATIONS:

QUESTIONS:

PACKAGE DISPLAY LABEL:

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?