Label: GABA PHENOLIC - .gamma.-aminobutyric acid liquid
- NDC Code(s): 57520-0378-1
- Packager: Apotheca Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
ACTIVE INGREDIENTS: Gamma-aminobutyric acid 6X, 12X, 30X, 12X, 30C.Close
INDICATIONS: To be used according to standard homeopathic indications.Close
WARNINGS: If pregnant or breast-feeding, 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.Close
- DOSAGE & ADMINISTRATION
SUGGESTED USE: Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.Close
- INACTIVE INGREDIENT
INACTIVE INGREDIENTS: Demineralized water, 20% EthanolClose
201 Apple Blvd.
Woodbine, IA 51579
- PRINCIPAL DISPLAY PANEL
1 fl. oz. (30 ml)
- INGREDIENTS AND APPEARANCE
gamma-aminobutyric acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0378 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I) .GAMMA.-AMINOBUTYRIC ACID 30 [hp_C] 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:57520-0378-1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/03/2010 Labeler - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture