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 
Amore Energia, LLC

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.

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Drug Facts:

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)

Pain Suppress for Men

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:71166-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK30 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H) BOS TAURUS TESTICLE30 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_X]  in 1 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF30 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT30 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71166-0003-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/18/201807/27/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/18/201807/27/2022
Labeler - Amore Energia, LLC (080487870)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(71166-0003) , api manufacture(71166-0003) , label(71166-0003) , pack(71166-0003)

Revised: 1/2021
 
Amore Energia, LLC