TULA TANTRUM TAMER- chamomilla, cina pellet

Tula Tantrum Tamer by

Drug Labeling and Warnings

Tula Tantrum Tamer by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, OHM Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients

HPUS Active Ingredients: Equal parts of each ingredient in a 6C potency: Chamomilla, Cina.

Uses*

Uses*: Homeopathic remedy for tantrums in young children

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

Warnings

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions For all ages: Take 5 pilules 2 times daily. Alternatively, for small babies, crush pilules onto tongue.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added. Lactose-free.

Tamper resistant for your protection. Use only if safetey seal is in tact.

Inactive Ingredients

Inactive Ingredients: Organic Sucrose

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Reduces restlessness & tantrums in children

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TULA TANTRUM TAMER 
chamomilla, cina pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-365
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT)	ARTEMISIA CINA FLOWER	6 [hp_C]  in 26 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 26 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (white to off-white)	Score
Shape	ROUND (roughly spherical)	Size	3mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-365-20	26 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/22/2021

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc.		030572478	manufacture(68703-365)