NDC 17089-350 Guna-awareness

Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human -

NDC Product Code 17089-350

NDC CODE: 17089-350

Proprietary Name: Guna-awareness What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human - What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
  • Coenzyme Q10 has been used for heart problems (e.g., heart failure, angina), high blood pressure, Parkinson's disease, gum disease, and certain diseases passed down through families (Huntington's disease, muscular dystrophy). It has also been used for reducing the number of migraine headaches and for reducing cell damage that may occur after surgery or treatment with certain anti-cancer drugs. If you have or think you have any of the conditions listed above, consult your doctor for advice on proper care and treatment. Coenzyme Q10 is a substance that your body normally makes. Your body uses it to help keep in good health. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • Drug uses not available
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • Melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes (jet lag). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time. Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • Drug uses not available
  • Drug uses not available
  • This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). Decreasing high homocysteine levels may help prevent serious blood clots, abnormal bone formation, brittle bones (osteoporosis), and eye problems (e.g., dislocated eye lens, nearsightedness). This medication works by decreasing blood levels of homocysteine. It does not correct the inherited disorder that causes the disease.
  • Drug uses not available

NDC Code Structure

NDC 17089-350-18

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Guna-awareness with NDC 17089-350 is a a human over the counter drug product labeled by Guna Spa. The generic name of Guna-awareness is betaine - bufo bufo cutaneous gland - calcium carbonate - chromic sulfate - cicuta virosa root - copper - folic acid - gold - cobalamin - iron - lachesis muta venom - melatonin - molybdenum - neurotrophin-3 - neurotrophin-4 - oxytocin - silicon dioxide - sus scrofa frontal lobe - sus scrofa temporal lobe - thyrotropin alfa - ubidecarenone - vanadium - zinc - brain-derived neurotrophic factor human -. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Guna Spa

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Guna-awareness Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GOLD 12 [hp_X]/30mL
  • BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 4 [hp_C]/30mL
  • BUFO BUFO CUTANEOUS GLAND 12 [hp_X]/30mL
  • CALCIUM CARBONATE 3 [hp_X]/30mL
  • CHROMIC SULFATE 3 [hp_X]/30mL
  • CICUTA VIROSA ROOT 12 [hp_X]/30mL
  • COBALAMIN 3 [hp_X]/30mL
  • UBIDECARENONE 3 [hp_X]/30mL
  • COPPER 12 [hp_X]/30mL
  • IRON 3 [hp_X]/30mL
  • FOLIC ACID 3 [hp_X]/30mL
  • SUS SCROFA FRONTAL LOBE 6 [hp_X]/30mL
  • LACHESIS MUTA VENOM 12 [hp_X]/30mL
  • MELATONIN 4 [hp_C]/30mL
  • MOLYBDENUM 3 [hp_X]/30mL
  • NEUROTROPHIN-3 4 [hp_C]/30mL
  • NEUROTROPHIN-4 4 [hp_C]/30mL
  • OXYTOCIN 6 [hp_X]/30mL
  • SILICON DIOXIDE 12 [hp_X]/30mL
  • SUS SCROFA TEMPORAL LOBE 6 [hp_X]/30mL
  • THYROTROPIN ALFA 3 [hp_X]/30mL
  • BETAINE 3 [hp_X]/30mL
  • VANADIUM 6 [hp_X]/30mL
  • ZINC 3 [hp_X]/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Guna Spa
Labeler Code: 17089
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-16-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Guna-awareness Product Label Images

Guna-awareness Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients/Purpose

AURUM METALLICUM                                    12X    ANTIDEPRESSANTBRAIN DERIVED NEUROTROPHIC FACTOR     4C    HELPS MENTAL ACTIVITYBUFO RANA                                                    12X    HELPS MENTAL ACTIVITYCALCAREA CARBONICA                                3X    IMMUNE STRENGTHENINGCHROMIUM SULPHURICUM                            3X    DETOXIFICATIONCICUTA VIROSA                                            12X    ANTISPASTICCOBALAMIN                                                    3X    ANTIOXIDANTCOENZYME Q                                                3X    ANTIOXIDANTCUPRUM METALLICUM                                12X    ANTISPASTICFERRUM METALLICUM                                3X    ANTIOXIDANTFOLIC ACID                                                  3X    ANTIOXIDANTFRONTAL LOBE                                        6X    SUPPORTS COORDINATING BEHAVIORLACHESIS MUTUS                                    12X    ANTI-INFLAMMATORYMELATONIN                                             4C    ANTISTRESSMOLYBDENUM METALLICUM                   3X    ANTIAGINGNEUROTROPHIN 3                                    4C    SUPPORTS MENTAL ACTIVITYNEUROTROPHIN 4                                    4C    SUPPORTS MENTAL ACTIVITYOXYTOCIN                                                6X    ANTISPASTICSILICEA                                                    12X    IMMUNE STRENGTHENINGTEMPORAL LOBE                                        6X    SUPPORTS AUDITORY PROCESSINGTHYROTROPIN-RELEASING HORMONE        3X    HELPS MENTAL ACTIVITYTRIMETHYLGLYCINE                                3X    DETOXIFICATIONVANADIUM METALLICUM                        6X    ANTIOXIDANTZINCUM METALLICUM                            3X    ANTISTRESS

Uses

For the temporary relief of symptoms of Impaired Cognitive Function such as: Inability to Concentrate, Restlessness, Easy distractibility

Warnings

Stop use and ask doctor if symptoms of  Inability to Concentrate, Restlessness, Easy distractibility  worsen or persist more than 5 days

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Take 15 minutes before mealsAdults and children 12 years and older    20 drops in a little water, 2 times per dayChildren  between 12 years and 6 years of age    10 drops in a little water, 2 times per dayChildren under 6 years     5 drops in a glass of water, 2 times per day

Questions

Questions?: info@gunainc.com, tel. (484) 223-3500

* Please review the disclaimer below.