Search by Drug Name or NDC

NDC 71742-0006-01 Sleep Well 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Sleep Well 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Sleep Well is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Guangzhou Renuma Medical Systems Co., Ltd. The primary component is ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN.

Product Information

NDC	71742-0006
Product ID	71742-0006_76adb01c-5f32-4d49-abfc-adfbd560d699
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	Sleep Well
Proprietary Name Suffix	T012
Non-Proprietary Name	Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	30; 30; 30; 30; 30; 30; 30; 30; 30
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Labeler Name	Guangzhou Renuma Medical Systems Co., Ltd
Pharmaceutical Class	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [E
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71742-0006-01 (71742000601)

Pricing Information	N/A
NDC Package Code	71742-0006-1
Billing NDC	71742000601
Package	59 mL in 1 BOTTLE, DROPPER (71742-0006-1)
Marketing Start Date	2017-10-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2dc9026a-b847-403b-a92e-5d629e4b3c68 Details

ACTIVE INGREDIENTS:

Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

INDICATIONS:

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

WARNINGS:

If pregnant or breast-feeding, ask a health care 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 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:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve symptoms due to fatigue and restlessness from inability to sleep.

INACTIVE INGREDIENTS:

Demineralized water, Glycerin

QUESTIONS:

Distributed by:

Guangzhou Renuma Medical

Systems Co., Ltd.

No. 5, 2nd Floor, Ascendas 2nd Street

Sino-Singapore Guangzhou Knowledge City

Guangzhou 510555, China

PACKAGE LABEL DISPLAY:

SLEEP WELL

T012

HOMEOPATHIC

2 fl. oz. (59 ml)

INGREDIENTS AND APPEARANCE

SLEEP WELL T012

arsenicum album, avena sativa, coffea cruda, kali carbonicum, magnesia carbonica, nux vomica, passiflora incarnata, sepia, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71742-0006
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	30 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	30 [hp_X] in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	30 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	30 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71742-0006-1	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/24/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/24/2017

Labeler - Guangzhou Renuma Medical Systems Co., Ltd (544538706)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71742-0006) , api manufacture(71742-0006) , label(71742-0006) , pack(71742-0006)

Revised: 10/2017

Document Id: 76adb01c-5f32-4d49-abfc-adfbd560d699

Set id: 2dc9026a-b847-403b-a92e-5d629e4b3c68

Version: 1

Effective Time: 20171024

Search by Drug Name or NDC

NDC 71742-0006-01 Sleep Well 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Sleep Well 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [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 71742-0006-01 (71742000601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2dc9026a-b847-403b-a92e-5d629e4b3c68 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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