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NDC 71094-0001-01 Tinnistop 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Tinnistop 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1

Tinnistop is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Peerless Homeopathic. The primary component is ANAMIRTA COCCULUS SEED; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP.

Product Information

NDC	71094-0001
Product ID	71094-0001_ce0797a6-6848-4329-9ced-2b24165f584a
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	Tinnistop
Proprietary Name Suffix	n/a
Non-Proprietary Name	Causticum, Cocculus Indicus, Conium Maculatum
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	6; 6; 6
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ANAMIRTA COCCULUS SEED; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP
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 71094-0001-01 (71094000101)

Pricing Information	N/A
NDC Package Code	71094-0001-1
Billing NDC	71094000101
Package	100 TABLET in 1 BOTTLE (71094-0001-1)
Marketing Start Date	2017-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 22f0281d-d8cf-40da-9ac6-ef3a89e748f5 Details

ACTIVE INGREDIENTS:

Causticum 6X, Cocculus Indicus 6X, Conium Maculatum 6X

USES:

For the temporary relief of ringing, roaring, humming, buzzing, and noise sensitivity in the ears.

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:

While following the Online Dosage Guide*, take 1 tablet up to 3 times a day as needed. Store in a cool dry place.

INDICATIONS:

For the temporary relief of ringing, roaring, humming, buzzing, and noise sensitivity in the ears.

INACTIVE INGREDIENTS:

Lactose, Magnesium Stearate, Microcrystalline Cellulose

QUESTIONS:

*Online Dosage Guide and more information at:

www.TinniStop.com

Quality manufactured for and distributed by:

Peerless Homeopathic

PO Box 5083 Charlottesville, VA 22905

PACKAGE LABEL DISPLAY:

TINNISTOP

Tinnitus Relief Guaranteed

Ringing

Humming

Buzzing

Roaring

Natural Homeopathic

Patent Pending 100 Tablets

INGREDIENTS AND APPEARANCE

TINNISTOP

causticum, cocculus indicus, conium maculatum tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71094-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X]
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	6 [hp_X]
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	6 [hp_X]

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71094-0001-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/17/2017

Labeler - Peerless Homeopathic (032675012)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71094-0001) , api manufacture(71094-0001) , label(71094-0001) , pack(71094-0001)

Revised: 1/2017

Document Id: ce0797a6-6848-4329-9ced-2b24165f584a

Set id: 22f0281d-d8cf-40da-9ac6-ef3a89e748f5

Version: 1

Effective Time: 20170117