FDA Label for Rite Aid Natural Fiber Orange Flavor

View Indications, Usage & Precautions

Rite Aid Natural Fiber Orange Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient: (In Each Tablespoon)



Psyllium husk approximately 3.4 g


Purpose



Fiber therapy for regularity


Uses:



  • •for relief of occasional constipation (irregularity)

Choking



Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.


Allergy Alert:



This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.


Otc - Ask Doctor



Ask a doctor before use if you have

  • ▪a sudden change in bowel habits persisting for 2 weeks
  • ▪abdominal pain, nausea or vomiting

Otc - Stop Use



Stop use and ask a doctor if

  • ▪constipation lasts more than 7 days
  • ▪rectal bleeding occurs
  • These may be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Directions:



Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults 12 years & older:

1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

6 – 11 yrs :

½ adult dose in 8 oz of liquid, up to 3 times daily

Under 6 yrs:

Consult a doctor

Bulk forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.


New Users



Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.


Other Information:



  • •each tablespoon contains: potassium 35 mg; sodium 5 mg
  • •store at room temperature. tightly closed to protect from humidity
  • •do not use if printed inner seal is broken or missing
  • •contains a 100% natural, therapeutic fiber

Inactive Ingredients



citric acid, FD &C yellow 6, natural and artificial orange flavor, silica, sucrose


Questions Or Comments?



1-866-467-2748


Principal Display Panel



RITE AID PHARMACY®

NDC 11822-5131-4

Compare to the active ingredient in Metamucil® 4 in 1 MultiHealth Fiber

Multi-Health Fiber Supplement

Psyllium husk 3.4 g

Daily fiber supplement/therapy for regularity

100% NATURAL PSYLLIUM FIBER POWDER

  • •Helps you feel less hungry between meals**
  • •Helps maintain healthy blood sugar levels as part of your diet**
  • •Helps lower cholesterol to promote heart health**
  • •Promotes digestive health**
  • •Gluten free
  • ORANGE FLAVOR

    NATURALLY & ARTIFICIALLY FLAVORED

    114 TABLESPOON‡

    NET WT 48.2 OZ (3 LB) 1.37 g

    fill controlled by weight, not volume

    †See back for information about soluble fiber and heart disease.

    ‡Serving size varies. See DIRECTIONS on back panel for more information

    **These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

    DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Procter & Gamble Company, Owner of the registered trademark Metamucil ®.

    GLUTEN FREE (If you have specific dietary needs, you should consult your doctor before consuming this product.)

    This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

    SATISFACTION GUARANTEE

    IF YOU’RE NOT SATISFIED, WE’LL HAPPILY REFUND YOUR MONEY.

    Patent no: 6.361.799

    DISTRIBUTED. BY:

    RITE AID, 30 HUNTER LANE

    CAMP HILL, PA 17011


* Please review the disclaimer below.