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Drug Facts
Lidl Orange Smooth Fiber Powder Sugar Free Powder
FDA Label NDC 71141-146
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lidl Us, Llc for the product Lidl Orange Smooth Fiber Powder Sugar Free (NDC 71141-146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient: (in each teaspoon), purpose, uses:, choking:, allergy alert:, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 increased 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 100% natural, therapeutic fiber▪ store at room temperature 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?
1-844-656-5151
Principal Display Panel
SUGAR FREE
NDC 71141-146-32
ORANGE SMOOTH
FIBER POWDER NATURALLY & ARTIFICIALLY FLAVORED
Compare to Psyllium in Metamucil® 4 in 1 Multihealth Fiber*
Fiber POWDER
100% NATURAL PSYLLIUM HUSK
Bulk forming laxative/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**▪ Gluten free
NET WT 23 OZ (660g)
fill controlled by weight, not volume
†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. |
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*.
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.
DISTRIBUTED BY:
Lidl US, LLC
3500 S. Clark Street
Arlington, VA 22202
QUESTIONS?
1-844-656-5151
www.lidl.com
Lidl Sugar Free Orange Smooth Natural Psyllium Husk (51572pvlr)
* Please review the disclaimer below.
