DRINITES- causticum, equisetum hyemale, sepia tablet

DriNites by

Drug Labeling and Warnings

DriNites by is a Homeopathic medication manufactured, distributed, or labeled by Peerless Homeopathic, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Peerless Homeopathic (032675012)

Registrant - Apotheca Company (844330915)

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