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NDC 71094-0002-01 DriNites 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 Details

DriNites 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1

DriNites is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Peerless Homeopathic. The primary component is CAUSTICUM; EQUISETUM HYEMALE; SEPIA OFFICINALIS JUICE.

Product Information

NDC	71094-0002
Product ID	71094-0002_41303cb2-51b9-4877-a1e0-a215707a7355
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	DriNites
Proprietary Name Suffix	n/a
Non-Proprietary Name	Causticum, Equisetum Hyemale, Sepia
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	6; 6; 6
Active Ingredient Units	[hp_C]/1; [hp_C]/1; [hp_C]/1
Substance Name	CAUSTICUM; EQUISETUM HYEMALE; SEPIA OFFICINALIS JUICE
Labeler Name	Peerless Homeopathic
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 71094-0002-01 (71094000201)

Pricing Information	N/A
NDC Package Code	71094-0002-1
Billing NDC	71094000201
Package	100 TABLET in 1 BOTTLE (71094-0002-1)
Marketing Start Date	2017-09-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b83b014a-9543-4297-952c-bd54cd9abc0d Details

ACTIVE INGREDIENTS:

Causticum 6C, Equisetum Hyemale 6C, Sepia 6C.

USES:

For the temporary relief of bedwetting in children (nocturnal enuresis).

WARNINGS:

Do not use if safety seal is broken or missing.

A physician should always be consulted to rule out serious causes.

If pregnant or breast feeding, ask a physician before use. If symptoms persist, consult a physician.

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

OTHER INFORMATION:

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS) and are non-toxic with no known side effects.

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:

Dissolve 2 tablets under the tongue at dinner and 2 more at bedtime. Store in a cool dry place.

INDICATIONS:

For the temporary relief of bedwetting in children (nocturnal enuresis).

INACTIVE INGREDIENTS:

Lactose, Magnesium Stearate, Microcrystalline Cellulose

QUESTIONS:

For more information please visit:

www.DriNites.com

Quality manufactured for and distributed by:

Peerless Homeopathic

PO Box 5038 Charlottesville, VA 22905

PACKAGE LABEL DISPLAY:

DriNites

Bedwetting Relief

100% Natural

No Side Effects

Dissolving Tabs

Homeopathic 100 Tablets

INGREDIENTS AND APPEARANCE

DRINITES

causticum, equisetum hyemale, sepia tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71094-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_C]
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	6 [hp_C]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	6 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (CONVEX)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	DIAMOND
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71094-0002-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/13/2017

Labeler - Peerless Homeopathic (032675012)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71094-0002) , api manufacture(71094-0002) , label(71094-0002) , pack(71094-0002)

Revised: 9/2017

Document Id: 41303cb2-51b9-4877-a1e0-a215707a7355

Set id: b83b014a-9543-4297-952c-bd54cd9abc0d

Version: 1

Effective Time: 20170913