Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 70026fcd-9d22-4cfb-acd3-5533822d5e26
Route
ORAL
Published
Effective Date 2017-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (1 [hp_X]) Silybum Marianum Seed (3 [hp_X]) Turnera Diffusa Leafy Twig (6 [hp_X]) Galium Aparine (2 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark (30 [hp_X]) Beef Liver (200 [hp_C]) Asian Ginseng Nuphar Luteum Root Bos Taurus Testicle Populus Tremuloides Bark Populus Tremuloides Leaf Testosterone Thuja Occidentalis Leaf
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-09-16

Description

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.


Medication Information

Description

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

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.

Questions:

Distributed By ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

Directions:

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

Indications:

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

Active Ingredients:

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

Inactive Ingredients:

Purified Water, Organic Ethanol 30%

Package Label Display:

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL OZ (30 ML)

proBLEN

Keep Out of Reach of Children:

​Keep out of the reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed By ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

Directions: (DIRECTIONS:)

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

Indications: (INDICATIONS:)

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

Active Ingredients: (ACTIVE INGREDIENTS:)

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Organic Ethanol 30%

Package Label Display: (PACKAGE LABEL DISPLAY:)

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL OZ (30 ML)

proBLEN

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

​Keep out of the reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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