Label: HGH (human growth hormone (2 parts), hypophysis suis (2 parts), hepar suis- 1 part spray
- NDC Code(s): 43853-0013-1
- Packager: ProBLEN
- 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 November 23, 2016
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
Not for use on children.
If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.
As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Tamper Evident. There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HGH
human growth hormone (2 parts), hypophysis suis (2 parts), hepar suis (1 part) sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43853-0013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL) SOMATROPIN 30 [hp_X] in 1 mL SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND 30 [hp_X] in 1 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 6 [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:43853-0013-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/23/2016 Labeler - ProBLEN (838787161) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43853-0013) , api manufacture(43853-0013) , label(43853-0013) , pack(43853-0013)