Active Ingredient (In Each Dose)
Psyllium Hydrophilic Mucilloid 6 grams
Cvs Health Powder
FDA Label NDC 69842-524
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health (NDC 69842-524). 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 active ingredient (in each dose), purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-Forming Laxative
Use
for relief of occasional constipation and to induce regularity. Generally produces bowel movements within 12-72 hours.
Warnings
Allergy alert: As with any natural grain product, inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to 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.
Do Not Use
laxative products when abdominal pain, nausea or vomiting is present unless directed by a doctor.
Ask A Doctor Before Use If You Have
▪ a sudden change in bowel habits that persists over a period of two weeks
Stop Use And Ask A Doctor If
▪ you experience rectal bleeding▪ you fail to have a bowel movement
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
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 fluid may cause choking. See choking warnings.
Adults and children 12 years and older: put one dose (one rounded teaspoonful) into a shaker cup or closed container; add a least 8 oz. of juice, water or other beverage ;shake 3 to 5 seconds; drink promptly; if mixture thickens and more fluid, stir; follow with additional fluid to aid product action ;take 1-3 times daily.
Children 6 years to under 12 years: 1/2 adult dose, in 8 oz. of fluid; 1-3 times daily.
Children under 6 years: ask adoctor.
Other Information
▪ each 6.0 gram dose contains: Calcium 10 mg, Potassium 55 mg, Sodium 5 mg▪ maximum daily dose (3 teaspoonful) is very low in sodium▪ Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines.▪ No additives, No sugars, gluten free. No flavors ,100% Natural▪ Safe for diabetics, non-habit-forming▪ tamper-evident bottle mouth sealed for your protection▪ do not use if imprinted inner seal is broken or missing▪ store below 86 °F (30°C)▪ keep container tightly closed-protect from excessive moisture▪ can be taken 1 to 3 times daily, before or after meals, mornings or evenings
Inactive Ingredients
water
Principal Display Panel
CVS Health™
*Compare to active ingredients in Konsyl Original Formula®
NDC# 69842-524-75
Natural Fiber Supplement
100% Natural Psyllium Fiber
Fiber Supplement
Helps lower cholesterol to promote heart health
Helps Support
- Diabetes management
- Digestive health
- Healthy weight
6g
FIBER
Healthy Heart Formula
75 TEASPOON DOSES
NET WT 450 g (15.9 OZ)
(FILL CONTROLLED BY WEIGHT, NOT VOULUME)
Do not discard powder into any plumbing systems.
†These statement have not been evaluated by the Food and Drug Administration. To diagnose, treat cure or prevent any disease.
*This product is not manufactured or distributed by Konsyl Pharmaceuticals, the manufactured of Konsyl®
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