AMERICANA WHEY PROTEIN SUPPLEMENT- whey protein concentrated powder

AMERICANA WHEY Protein Supplement by

Drug Labeling and Warnings

AMERICANA WHEY Protein Supplement by is a Other medication manufactured, distributed, or labeled by Pharmin USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HIGHLIGHTS OF PRESCRIBING INFORMATION Protein Supplement

Americana Whey- protein supplement powder for ORAL use

Artificial Bovine Growth Hormone Free

Non-GMO

1. INDICATIONS AND USAGE:

Americana Whey is a source of essential branched-chain amino acids (BCASS) leucine, isoleucine, and valine. Americana Whey helps forming blood vessels, supporting immune systems and regulating metabolism. Americana Whey recovers muscle fatigue from post workout as well as it helps building and repairing muscles.

2. DOSAGE AND ADMINISTRATION

One serving daily to supplement the diet with additional protein or as directed by a healthcare professional. For best results, blend with a beverage high in carbohydrates and take between meals or after training. Do not use this product as a meal replacement or exceed suggested use without the supervision of a healthcare professional.

3. DOSAGE FORMS AND STRENGTHS

Dry Powder 22.5 mg protein per 30 grams (1 scoop)

4. CONTRA-INDICATIONS

History of hypersensitivity to any of the components in the formula.

5. WARNINGS AND PRECAUTIONS

rGBH growth is a genetically engineered artificial growth hormone injected into dairy cows to increase milk production. The growth hormones can lead to utter infections, which are treated with antibiotics. Both rBGH growth hormones and antibiotics can then be passed on to humans through the milk. Americana Whey is rGBH free product.

6. MECHANISM OF ACTION

Cells growth via carrying essential amino acids.

7. DRUG INTERACTIONS

Severe interactions were not reported. Nevertheless, to avoid interactions with other drugs, the patient shall inform the physician if she/he is taking another medicine.

8. ADVERSE REACTIONS

May cause stomach upset. If occurred take it after meals.

9. PRECAUTIONS

This product has been ordered for a particular condition, therefore, it should not be used for other conditions and not give to anyone else. Keep this and all medicines out of the reach of children. This product should not be used after expiration date.

10. PREGNANCY AND LACTATION

There is no available data to evaluate teratogenic or fetotoxic effects. Therefore, it should not be used during pregnancy and lactation.

11. OVERDOSAGE

Non-reported

12. EFFECTS ON ABILITY TO DRIVE

Non-reported

13. HOW SUPPLIED/STORAGE AND HANDLING

Americana Whey protein supplement, intended for oral administration, is white powder containing 22.5 grams per serving supplied as follows:

NDC: 70586-1356-4 907 grams bottles

14. STORAGE:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

15. INGREDIENTS

Whey protein concentrate and Sunflower Lecithin.

Package label principal display panel (2 LBS- 907 GRAMS)

NDC: 70586-1356-4

AMERICAN WHEY protein supplement

• 22.5 grams of protein per serving
• 4 grams of carbohydrates
• Low fat
• Unflavored
• Solubility over a wide pH range
• Excellent emulsification properties
• Foam stability
• Gelation and water-binding properties
• Available with sunflower and no side effects such as upset stomach and bloating
• Clear with little cloudiness
• Low in fats and lactose
• Compatible with all juices, milk and easily dissolvable

Supplement Facts Serving Size 30 Grams (1 scoop); Serving Per Container:30
Amount Per Serving
Calories 120			Calories from Fat 15
			% Daily Value*
Total Fat 1.5 g			2 %
Saturated Fat 1 g			5 %
Trans Fat 0g			0 %
Cholesterol 54 mg			18%
Sodium 53 mg			1%
Potassium 172 mg			5%
Total Carbohydrate 4 g			1 %
Dietary Fiber 0g			0 %
Sugars 2.5 g
Protein 22.5 g
Vitamin A less that 1%			VitaminC Less that 1%
Calcium 12 %			Iron 1%
*Percent Daily Values are based on a 2,000 Calories diet. Your daily value may be higher or lower depending on your calorie needs.
	Calories	2000	2500
Total Fat	LessThan	65g	80g
Sat.Fat	LessThan	20g	25g
Cholesterol	LessThan	300mg	300mg
Sodium	LessThan	2400mg	2400mg
Total carbohydrates		300g	375g
Dietary Fiber		25g	30g
Calories per gram:
Fat 9 Carbohydrate 4 protein 4-Cyvex Nutrition dba Nutegrity

SUGGESTED USE:

1 serving daily to supplement the diet with additional protein or as directed by a healthcare professional. For best results, blend with a beverage high in carbohydrates and take between meals or after training. Do not use this product as a meal replacement or exceed suggested use without the supervision of a healthcare professional.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

DO NOT USE IF SAFETY SEAL IS DAMAGED OR MISSING. STORE IN A COOL, DRY PLACE.

Americana Whey is manufactured in a FDA and GMP certified facility.

Manufactured For:

Pharmin USA, LLC
2375 Lindbergh Avenue
San Jose, California 95128
United States of America

www.pharminusa.com

*Americana Whey is a registered Trademark of Pharmin USA, LLC.

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

AMERICANA WHEY PROTEIN SUPPLEMENT 
whey protein concentrated powder

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:70586-1356
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	80 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70586-1356-4	907 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		06/01/2010

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color

Labeler - Pharmin USA, LLC (025964216)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmin USA, LLC		025964216	manufacture(70586-1356)