Label: CAREONE- psyllium husk capsule
- NDC Code(s): 41520-907-60
- Packager: FOODHOLD USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Uses
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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
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- a sudden change in bowel habits persisting for 2 weeks
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- abdominal pain, nausea or vomiting
Stop use and ask a doctor if
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- constipation lasts more than 7 days
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- rectal bleeding occurs
These may be signs of a serious condition.
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Directions
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- 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.
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- 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.
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- children 12 years and under: Ask a doctor
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- 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.
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- As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 160 Capsules Label
NDC 41520-907-60
Compare to Metamucil® Capsules 3 in 1 Multihealth Fiber!™
FIBER CAPSULES
Psyllium Husk Fiber Supplement
100% natural Psyllium Husk
BULK FORMING LAXATIVE
DIETARY FIBER SUPPLEMENT160 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!™.
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INGREDIENTS AND APPEARANCE
CAREONE
psyllium husk capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-907 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G) Psyllium Husk 0.52 g Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 21mm Flavor Imprint Code RP119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-907-60 160 in 1 BOTTLE; Type 0: Not a Combination Product 04/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/16/2019 Labeler - FOODHOLD USA (809183973)
