BIRTH-HEAL- angelica, arnica, mag phos, passiflora, silicea tablet

Birth-Heal by

Drug Labeling and Warnings

Birth-Heal by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Reduces swelling and bruising after childbirth - with Arnica

ACTIVE INGREDIENT

Active Ingredients: Each serving contains equal parts of: Angelica 6X HPUS, Arnica 6C HPUS, Mag phos 8X HPUS, Passiflora 3X HPUS, Silicea 8X HPUS.

INDICATIONS & USAGE

Uses: Homeopathic remedy for common post-birth swelling, pain and soreness.

WARNINGS

Warnings: If symptoms persist or worsen, consult a healthcare professional.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Adults: On first day, take 2 tablets every 2 hours after childbirth. Thereafter, take 4 tablets 3 times per day for 3 weeks.

INACTIVE INGREDIENT

Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn starch, sucrose.

INFORMATION FOR PATIENTS

The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: +1.561.999.8857

Contains no artificial flavors or artificial colors. No gluten added.

STORAGE AND HANDLING

Tamper resistant for your protection. Use only if safety seal is intact.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIRTH-HEAL 
angelica, arnica, mag phos, passiflora, silicea tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-033
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	6 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_C]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (White lactose tablets)	Score	no score
Shape	ROUND (Round white lactose tablets)	Size	5mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-033-80	180 in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2012

Labeler - Native Remedies, LLC (192014186)

Registrant - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-033) , manufacture(68703-033)