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NDC 63083-9641-01 Heart Drops 12 [hp_X]/29.5mL Details

Heart Drops 12 [hp_X]/29.5mL

Heart Drops is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Professional Complementary Health Formulas. The primary component is BEEF HEART.

Product Information

NDC	63083-9641
Product ID	63083-9641_1f26093f-5c02-4219-b402-934dd5059d62
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	Heart Drops
Proprietary Name Suffix	9641
Non-Proprietary Name	Heart Drops
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12
Active Ingredient Units	[hp_X]/29.5mL
Substance Name	BEEF HEART
Labeler Name	Professional Complementary Health Formulas
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63083-9641-01 (63083964101)

Pricing Information	N/A
NDC Package Code	63083-9641-1
Billing NDC	63083964101
Package	29.5 mL in 1 BOTTLE, DROPPER (63083-9641-1)
Marketing Start Date	1985-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a1f85fe-d3a7-4af1-897d-c516c0c547cd Details

ACTIVE INGREDIENTS

Heart 12X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of mild abdominal or chest pain, exhaustion, general weakness, or dizziness.*

SPL UNCLASSIFIED SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

Seek medical attention immediately for severe symptoms such as chest pressure or tightness with radiation of the pain to the jaw and down the arm, shortness of breath, or sweating. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of the reach of children.

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Heart Drops

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

INGREDIENTS AND APPEARANCE

HEART DROPS 9641

heart drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63083-9641
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BEEF HEART (UNII: P47W069U38) (BEEF HEART - UNII:P47W069U38)	BEEF HEART	12 [hp_X] in 29.5 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63083-9641-1	29.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-9641)

Revised: 8/2019

Document Id: 1f26093f-5c02-4219-b402-934dd5059d62

Set id: 1a1f85fe-d3a7-4af1-897d-c516c0c547cd

Version: 1

Effective Time: 20190815