FDA Label for Topco Fiber Therapy Sugar Free
View Indications, Usage & Precautions
Topco Fiber Therapy Sugar Free Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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 Teaspoon)
Psyllium husk approximately 3.4 g
Purpose
Bulk-forming Laxative
Uses:
▪ for relief of occasional constipation (irregularity)▪ generally produces bowel movement in 12-72 hours
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 & children 12 years & older: | 1 rounded teaspoon in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily. |
Children 6-11 yrs : | ½ adult dose in 8 oz. of liquid, up to 3 times daily |
Children 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 3 doses per day as necessary. 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; sodium 5 mg▪ PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon▪ contains a therapeutic fiber▪ store at room temperature. Keep the container tightly closed to protect from humidity
Inactive Ingredients:
aspartame, citric acid, FD&C Yellow 6, maltodextrin, natural and artificial orange flavor, silica.
Questions Or Comments?
1-888-423-0139
Principal Display Panel
NDC 36800-558-80
COMPARE TO THE METAMUCIL® 4 IN 1 MULTIHEALTH FIBER! ™*
SUGAR FREE (NOT A LOW CALORIE FOOD)
Fiber Therapy
PSYLLIUM HUSK DAILY FIBER SUPPLEMENT THERAPY FOR REGULARITY
• Helps lower cholesterol to promote heart health†• Promotes digestive health**• Helps maintain healthy blood sugar levels as part of your diet**• Orange Smooth Fiber Powder• Gluten free
ORANGE FLAVOR
NATURALLY AND ARTIFICIALLY FLAVORED
180 TEASPOON‡ Doses
FILL CONTROLLED BY WEIGHT, NOT VOLUME
NET WT 36.8 OZ (2 LB 4.8 OZ) 1.04 kg
K
PAREVE
QUALITY GURANTEED
‡Serving size varies See DIRECTIONS on back panel for more information
†See back for information about soluble fiber and heart disease.
**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 of Metamucil® 4 in 1 MultiHealth Fiber!™.
This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.
This Top Care product is laboratory tested to guarantee its highest quality. You total satisfaction is guaranteed.
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
© TOPCO RARA1217
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
* Please review the disclaimer below.