TRIPLE COMPLEX SLEEP TONIC- cacl phos, calc sulph, mag phos tincture

Triple Complex Sleep Tonic by

Drug Labeling and Warnings

Triple Complex Sleep Tonic by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, Vitality Works. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Relieves sleepless in all ages

ACTIVE INGREDIENT

Active Ingredients: Each dose contains equal parts of: Calc phos 8X HPUS, Calc sulph 8X HPUS, Mag phos 8X HPUS

INDICATIONS & USAGE

Uses: Homeopathic remedy for peaceful slumber and sleep routine

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:For all ages: Acute: Take 0.25 mL or 0.50 mL every hour for up to 10 servings or until symptoms subside. Chronic: Take 0.25 mL or 0.50 mL 3 times daily

INACTIVE INGREDIENT

Inactive Ingredients: USP Purified Water, USP 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 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 animal products, gluten, artificial flavors, preservatives or colorants

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE COMPLEX SLEEP TONIC  
cacl phos, calc sulph, mag phos tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-069
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	8 [hp_X]  in 1 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	8 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X]  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: 68703-069-60	59 mL in 1 BOTTLE, GLASS

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

Labeler - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works		137752817	manufacture(68703-069) , api manufacture(68703-069)