Headache Ease: Homeopathic Product Information

HEADACHE EASE- potassium phosphate, dibasic, sepia officinalis juice, atropa belladonna, strychnos nux-vomica seed, gold, gelsemium sempervirens root, strychnos ignatii seed, bryonia alba root and sodium chloride tablet
Silver Star Brands

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

HPUS Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingredient in a 12C potency: Aur met, Belladonna, Bryonia, Gelsemium, Ignatia, Kali phos, Nat mur, Nux vom, Sepia.

Uses*

Uses*: Homeopathic relief of common headache symptoms.

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.

Directions

Directions: Chew or dissolve tablets int he mouth. For Adults and Children 12+: Take 2 tablets every 15-20 minutes up to 4 doses, then every 4 hours until symptoms subside.

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

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

Inactive Ingredients

Inactive Ingredients: Magnesium Stearate, Maltodextrin, Sucrose.

Keep this and all medication out of reach of children.

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

Temporarily relieves common headache symptoms*

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

HEADACHE EASE aur met, belladonna, bryonia, gelseisum, ignatia, kali phos, nat mur, nux vom, sepia tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-374 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) POTASSIUM PHOSPHATE, DIBASIC 12 [hp_C] in 180 SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 12 [hp_C] in 180 ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 12 [hp_C] in 180 STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 12 [hp_C] in 180 GOLD (GOLD) GOLD 12 [hp_C] in 180 GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_C] in 180 STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 12 [hp_C] in 180 BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 12 [hp_C] in 180 SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 12 [hp_C] in 180

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE MALTODEXTRIN SUCROSE

Product Characteristics Color white Score score with uneven pieces Shape ROUND Size 3mm Flavor Imprint Code NONE Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68703-374-80 180 TABLET in 1 BOTTLE, GLASS None

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Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/20/2021

Labeler — Silver Star Brands (006070379)

Registrant — Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Operations
OHM Pharma, Inc.		030572478	manufacture (68703-374)

Revised: 07/2021 Silver Star Brands