TULA TANTRUM TAMER- chamomilla, cina granule

Tula Tantrum Tamer by

Drug Labeling and Warnings

Tula Tantrum Tamer 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 restlessness and tantrums in children

ACTIVE INGREDIENT

Active Ingredients: Each dose contains equal parts of: Chamomilla 6C HPUS, Cina 6C HPUS

INDICATIONS & USAGE

Uses: Homeopathic remedy for tantrums in young children

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional

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: Take 5 pilules 2 times daily. Alternatively, for small babies, crush pilules and sprinkle onto tongue. Special instruction: Take on an empty stomach. Avoid strong mint flavored candy

INACTIVE INGREDIENT

Inactive Ingredients:Citric acid, corn starch, potassium sorbate, 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 manufactures 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

TULA TANTRUM TAMER 
chamomilla, cina granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-029
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 50 mg
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	6 [hp_C]  in 50 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCROSE (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-029-20	20000 mg in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2012

Labeler - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-029) , api manufacture(68703-029)