HEADACHE SOOTHE- chamomilla, cinchona, kali phos, mag phos, nux vom tincture

Headache Soothe by

Drug Labeling and Warnings

Headache Soothe by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, Vitality Works, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Relieves headache and nervous tension

ACTIVE INGREDIENT

Active Ingredients: Each dose contains equal parts of: Chamomilla 12C HPUS, Cinchona 12C HPUS, Kali phos 6X HPUS, Mag phos 12X HPUS, Nux vom 12C HPUS

INDICATIONS & USAGE

Uses: Homeopathic remedy for headache relief

WARNINGS

Warnings: If symptoms persist or worsen, consult a health care professional

PREGNANCY OR BREAST FEEDING

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

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 Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions: Adults and Children 13+: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 20-30 minutes as needed until symptoms subside. If preferred, drops may betaken directly into the mouth. Children under 13: Reduce serving size to 0.25 mL

INACTIVE INGREDIENT

Inactive Ingredients: USP Purified water, grain alcohol (20% by volume), Lactose

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 expert 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 animal products, glutenm artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEADACHE SOOTHE 
chamomilla, cinchona, kali phos, mag phos, nux vom tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_C]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	12 [hp_C]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	6 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LACTOSE (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-085-59	59 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2013

Labeler - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc		137752817	manufacture(68703-085) , api manufacture(68703-085)