Label: FIBER LAXATIVE- psyllium husk capsule
- NDC Code(s): 68163-119-25
- Packager: Raritan Pharmaceuticals Inc
- 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 September 1, 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 ounces. 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
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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.
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Other information
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- each capsule contains: potassium 5 mg
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- store at room temperature. Keep tightly closed to protect from humidity
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- contains a 100% natural, therapeutic fiber
WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 25 Capsules Label
NDC 68163-119-25
Compare to the active ingredient in Metamucil® Capsules 3 in 1 MultiHealth Fiber!™*
100% Natural Psyllium Husk
Fiber Capsules
Fiber Laxative/Dietary Supplement- •
- Helps maintain healthy blood sugar levels as part of your diet**
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- Helps lower cholesterol to promote heart health†
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- Promotes digestive health**
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- Gluten free (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product.
†See back for information about soluble fiber and heart disease
25 Capsules
Mfg. by: Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® Capsules 3 in1 MultiHealth Fiber!™.
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INGREDIENTS AND APPEARANCE
FIBER LAXATIVE
psyllium husk capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-119 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:68163-119-25 25 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 - Raritan Pharmaceuticals Inc (127602287)
