PAIN SUPPRESS FOR MEN (arnica montana, berberis vulgaris, chamomilla, hypericum perforatum, natrum muriaticum, nux vomica, orchitinum (bovine), plantago major, rhododendron chrysanthum, sarsaparilla- smilax regelii, sulphur, veratrum album liquid

Pain Suppress for Men by

Drug Labeling and Warnings

Pain Suppress for Men by is a Homeopathic medication manufactured, distributed, or labeled by Amore Energia, LLC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Arnica Montana 30X, Berberis Vulgaris 30X, Chamomilla 30X, Hypericum Perforatum 30X, Natrum Muriaticum 30X, Nux Vomica 30X, Orchitinum (Bovine) 30X, Plantago Major 30X, Rhododendron Chrysanthum 30X, Sarsaparilla (Smilax Regelii) 30X, Sulphur 30X, Veratrum Album 30X.

INDICATIONS:

May provide temporary relief of subjective pain due to inflammation and/or injury.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Shake before use.

Two sprays, within the mouth, three times a day.

Repeat daily, as needed for general relief.

Consult with your health care provider for use in children under 12 years of age.

INDICATIONS:

May provide temporary relief of subjective pain due to inflammation and/or injury.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 20%

QUESTIONS:

Dist. by Amore Energia, LLC

8001 Chicago Street

Omaha, NE 68114

PACKAGE LABEL DISPLAY:

Amore Energia

Pain Suppress

for Men

Homeopathic Spray

2 fl. oz. (60 ml)

INGREDIENTS AND APPEARANCE

PAIN SUPPRESS FOR MEN 
arnica montana, berberis vulgaris, chamomilla, hypericum perforatum, natrum muriaticum, nux vomica, orchitinum (bovine), plantago major, rhododendron chrysanthum, sarsaparilla (smilax regelii), sulphur, veratrum album liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71166-0003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	30 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	30 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X]  in 1 mL
BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H)	BOS TAURUS TESTICLE	30 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	30 [hp_X]  in 1 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	30 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	30 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	30 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71166-0003-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2018

Labeler - Amore Energia, LLC (080487870)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(71166-0003) , api manufacture(71166-0003) , label(71166-0003) , pack(71166-0003)