Label: FIBER LAXATIVE- psyllium husk capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 49348-633-49 - Packager: McKesson
- 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 April 10, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
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Directions
- take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
- swallow capsules one at a time
- daily maximum 3 doses
- dosage will vary according to diet, exercise, previous laxative use or severity of constipation.
- product generally produces effect in 12-72 hours.
adults and children 12 years and older 5 capsules, 1 to 3 times a day children 6 to under 11 years consider use of powder form of product children under 6 years ask a doctor - Laxatives, including bulk fibers, 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. 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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Fiber Supplement information
Uses: An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One serving of this product provides 2.4 grams of this soluble fiber. consult a doctor if you are considering use of this product as part of a cholesterol lowering program.
Warnings: Read entire label, including warnings in Drug Facts
Directions: Adults 12 years and older: 2-6 capsules for increasing daily fiber intake; 6 capsules for cholesterol lowering use. Take this product 8oz. of liquid (swallow 1 capsule at a time) up to 3 times daily. NOTICE: Take this product atleast 8 oz . (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing.
- PDP
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INGREDIENTS AND APPEARANCE
FIBER LAXATIVE
psyllium husk capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-633 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 520 mg Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) GELATIN (UNII: 2G86QN327L) BROWN IRON OXIDE (UNII: 1N032N7MFO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SHELLAC (UNII: 46N107B71O) Product Characteristics Color white (Clear transparent pale to buff color) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code G650 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-633-49 160 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/14/2003 Labeler - McKesson (177667227)
