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NDC 68428-0979-05 Macrotinum 30 [hp_C]/1 Details

Macrotinum 30 [hp_C]/1

Macrotinum is a ORAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Washington Homeopathic Products. The primary component is BLACK COHOSH.

Product Information

NDC	68428-0979
Product ID	68428-979_d2316874-e3ca-4c35-a620-9b5bca9b29e3
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	Macrotinum
Proprietary Name Suffix	n/a
Non-Proprietary Name	BLACK COHOSH
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	[hp_C]/1
Substance Name	BLACK COHOSH
Labeler Name	Washington Homeopathic Products
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 68428-0979-05 (68428097905)

Pricing Information	N/A
NDC Package Code	68428-979-05
Billing NDC	68428097905
Package	150 PELLET in 1 VIAL, GLASS (68428-979-05)
Marketing Start Date	2012-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f21847d4-3e3e-4560-9a3f-8f492106c035 Details

ACTIVE INGREDIENTS

MACROTINUM

USES

To relieve the symptoms of restlessness.

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of reach of children.

INDICATIONS

Indications:

MACROTINUM Restlessness

STOP USE AND ASK DOCTOR

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

DIRECTIONS

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

INACTIVE INGREDIENTS

Sucrose/Lactose

PRINCIPAL DISPLAY PANEL

The OTC potency range of MACROTINUM is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

Availability is subject to change.

All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

INGREDIENTS AND APPEARANCE

MACROTINUM

black cohosh pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68428-979
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	30 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68428-979-03	75 in 1 VIAL, GLASS; Type 0: Not a Combination Product	06/15/2012
2	NDC:68428-979-05	150 in 1 VIAL, GLASS; Type 0: Not a Combination Product	06/15/2012
3	NDC:68428-979-11	300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/15/2012
4	NDC:68428-979-12	600 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/15/2012
5	NDC:68428-979-06	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/15/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/15/2012

Labeler - Washington Homeopathic Products (084929389)

Name	Address	ID/FEI	Business Operations
Establishment
Washington Homeopathic Products		084929389	manufacture(68428-979)

Revised: 6/2012

Document Id: d2316874-e3ca-4c35-a620-9b5bca9b29e3

Set id: f21847d4-3e3e-4560-9a3f-8f492106c035

Version: 1

Effective Time: 20120615