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Drug Facts
Careone Capsule
FDA Label NDC 41520-907
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold Usa for the product Careone (NDC 41520-907). 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 capsule), purpose, uses, choking, allergy alert, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Capsule)
Psyllium husk approximately 0.52 g
Purpose
Fiber Laxative
Uses
▪ effective in treating occasional constipation and restoring regularity
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▪ constipation lasts more than 7 days▪ rectal bleeding occurs
Stop use and ask a doctor if
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
▪ Take this product 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.▪ Adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.▪ children 12 years and under: Ask a doctor▪ Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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.
Other Information
▪ each capsule contains: potassium 5 mg▪ capsules are sealed using a band around the middle▪ store at room temperature. Keep the container tightly closed to protect from humidity▪ contains a 100% natural, therapeutic fiber▪ tamper evident: do not use if printed inner seal under cap is broken or missing
Inactive Ingredients
caramel color, edible ink, gelatin, polysorbate 80
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 160 Capsules Label
NDC 41520-907-60
Compare to Metamucil® Capsules‡
FIBER CAPSULES
Psyllium Husk Fiber Supplement
100% natural Psyllium Husk
BULK FORMING LAXATIVE
DIETARY FIBER SUPPLEMENT
160 CAPSULES
OUR PHARMACISTS RECOMMEND
**THESE STAEMENTS HAVE NOT BEEN EVALUATED BY FOOD AND DRUG ADMINSTRATION, THIS PRODUCT IS NOT INTEDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE |
GLUTEN FREE (may contain trace amount less than 20 ppm). If you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product)
DISTRIBUTED BY FOODHOLD U.S.A. LLC
LANDOVER, MD 20785
1-877-846-9949
2018 S&S Brands, LLC
Quality guaranteed or your money back.
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 3 in1 MultiHealth Fiber!™.
Careone Fiber Capsules 160 Counts (119160pvlr Ol)
* Please review the disclaimer below.
