Label: STRESS / FATIGUE- epinephrine, thyroid unspecified,bos taurus pituitary gland, arsenic trioxide, oyster shell calcium carbonate crude, conium maculatum flowering top, cortisone acetate, crotalus horridus horridus venom, iron, strychnos nux-vomica seed, phosphoric acid, phosphorus, selenium, sepia officinalis juice, zanthoxylum americanum bark liquid
- NDC Code(s): 43406-0612-1
- Packager: Natural Creations, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 3, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
WARNINGS:
*Consult a physician for use in children under 12 years of age.
* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
* Do not use if TAMPER EVIDENT seal is broken or missing.
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
STRESS / FATIGUE
epinephrine, thyroid unspecified,bos taurus pituitary gland, arsenic trioxide, oyster shell calcium carbonate crude, conium maculatum flowering top, cortisone acetate, crotalus horridus horridus venom, iron, strychnos nux-vomica seed, phosphoric acid, phosphorus, selenium, sepia officinalis juice, zanthoxylum americanum bark liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0612 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 6 [hp_X] in 1 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 6 [hp_X] in 1 mL BOS TAURUS PITUITARY GLAND (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND 6 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 12 [hp_X] in 1 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM 12 [hp_X] in 1 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 12 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] in 1 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0612-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2016 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc. 030572478 manufacture(43406-0612)