FDA Label for Rite Aid Fiber Therapy
View Indications, Usage & Precautions
Rite Aid Fiber Therapy 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.
Active Ingredient (In Each Teaspoon)
Psyllium husk approximately 3.4 g
Purpose
Fiber therapy for regularity
Uses
▪ for relief of occasional constipation (irregularity)
Warnings
Allergy alert: This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
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.
Ask A Doctor Before Use If You Have
▪ abdominal pain, nausea or vomiting▪ a sudden change in bowel habits persisting for 2 weeks
Stop Use And Ask A Doctor If
▪ Constipation lasts more than 7 days▪ Rectal bleeding occurs
These may be signs of a serious condition.
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 thickness, add more liquid and stir.
Adults 12 years & older: | 1 rounded TEASPOON in 8 ounces of liquid at the signs of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours. |
Children 6-11 yrs: | ½ adult dose in 8 ounces 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 increase 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 teaspoon contains: potassium 35 mg and sodium 5 mg▪ PHENYLKETONURICS:CONTAINS PHENYLALANINE, 25 mg per teaspoon▪ Store at room temperature. Keep the container tightly closed to protect from humidity▪ Contains a 100% natural, therapeutic fiber
Inactive Ingredients
aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor, silica.
Questions Or Comments?
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RITE AID PHARMACY®
NDC# 11822-5151-4
Compare to the fiber content in Metamucil® 4 in 1 MultiHealth Fiber!™*
FIBER THERAPY
100% NATURAL PSYLLIUM HUSK
MULTI-BENEFIT DAILY FIBER SUPPLEMENT
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
SUGAR FREE
NOT A LOW CALORIE FOOD
SMOOTH ORANGE
NATURALLY & ARTIFICIALLY FLAVORED
**SEE BACK FOR INFORMATION ABOUT SOLUBLE FIBER AND HEART DISEASE.
114 TEASPOON DOSES
SERVING SIZE VARIES. SEE DIRECTIONS ON BACK PANEL FOR MORE INFORMATION
K PAREVE
NET WT. 23.3 OZ (1.4 LB) 660g
FILL CONTROLLED BY WEIGHT, NOT VOLUME
†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. |
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING |
*This product is not manufactured or distributed by Procter & Gamble, the distributor, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™*
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
* Please review the disclaimer below.