Label: AMERICANA WHEY PROTEIN SUPPLEMENT- whey protein concentrated powder

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 28, 2017

If you are a consumer or patient please visit this version.

  • 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 g2 %
    Saturated Fat 1 g5 % 
    Trans Fat 0g 0 %
    Cholesterol 54 mg18%
    Sodium 53 mg1%
    Potassium 172 mg5%
    Total Carbohydrate 4 g1 % 
               Dietary Fiber 0g0 %
               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 FatLessThan  65g80g
       Sat.FatLessThan20g25g
    CholesterolLessThan300mg300mg
    SodiumLessThan2400mg  2400mg
    Total carbohydrates300g375g
       Dietary Fiber25g30g
    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

    americana

  • INGREDIENTS AND APPEARANCE
    AMERICANA WHEY PROTEIN SUPPLEMENT 
    whey protein concentrated powder
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70586-1356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70586-1356-4907 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/01/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    Labeler - Pharmin USA, LLC (025964216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmin USA, LLC025964216manufacture(70586-1356)