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Up and up fiber therapy natural fiber - Medication Information

Product NDC Code 11673-668
Drug Name

Up and up fiber therapy natural fiber

Type Brand
Active Ingredients
Psyllium husk 3.4 g/12g
Route ORAL
Dosage Form POWDER
RxCUI drug identifier 824586
Application Number M007
Labeler Name Target Corporation
Packages
Package NDC Code Description
11673-668-90 1368 g in 1 bottle (11673-668-90)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient: (in each tablespoon) Psyllium husk approximately 3.4 g

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 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. 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. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. 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.
Adults & children 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.
Children 6 – 11 yrs:½ adult dose in 8 oz of liquid, up to 3 times daily
Children under 6 yrs: Consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients citric acid, FD &C yellow 6, natural and artificial orange flavor, silica, sucrose. Questions or comments? Call 1-800-910-6874

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: ▪ for relief of occasional constipation (irregularity)

Purpose

Information about the drug product’s indications for use.
Purpose Fiber therapy for regularity

Spl product data elements

Usually a list of ingredients in a drug product.
up and up fiber therapy Natural Fiber Psyllium Husk PSYLLIUM HUSK PSYLLIUM HUSK citric acid monohydrate FD&C Yellow No. 6 SILICON DIOXIDE SUCROSE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL NDC 11673-668-90 Compare to active ingredient in Metamucil® MultiHealth Fiber*** fiber therapy 100% natural psyllium husk multi-benefit daily fiber supplement therapy for regularity 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 ** not a low calorie food ORANGEFLAVOR 114 DOSES‡ Naturally and Artificially Flavored FILL CONTROLLED BY WEIGHT NOT VOLUME 114 TABLESPOON DOSES‡ NET WT 48.2 OZ (3 LB) 1368 g †See back for information about soluble fiber and heart disease. ‡Serving size varies. See DIRECTIONS on back panel for more information DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING ***This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®. GLUTEN FREE This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels. **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. 245 05 0308 R01 ID295403 Distributed by Target Corporation Minneapolis, MN 55403 ©2015 Target Brands, Inc. Shop Target.com up and up fiber therapy 100% natural psyllium husk
**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.

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks ▪ abdominal pain, nausea or vomiting

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-800-910-6874

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if ▪ constipation lasts more than 7 days ▪ rectal bleeding occurs These may be signs of a serious condition.

Storage and handling

Information about safe storage and handling of the drug product.
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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings: 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. Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks ▪ abdominal pain, nausea or vomiting 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API