Label: DISCOUNT DRUG MART ORANGE FLAVOR- psyllium husk natural fiber powder
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Contains inactivated NDC Code(s)
NDC Code(s): 53943-513-72 - Packager: DISCOUNT DRUG MART
- 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 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient: (in each tablespoon)
- 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
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Directions:
Put one dose into an empty glass. 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 liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults & children 12 years & older:
1 rounded tablespoon in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily.
Children 6-11 yrs :
½ adult dose in 8 oz of liquid, up to 3 times daily
Children under 6 yrs:
Consult a doctor
Laxatives, including bilk 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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PRINCIPAL DISPLAY PANEL
NDC 53943-513-72
Compare to the Fiber content in Metamucil® 4 in 1 MultiHealth Fiber™*
SMOOTH TEXTURE
Fiber Therapy
POWDER
Fiber Laxative/Fiber Supplement
100% Natural Psyllium Husk
SUGAR FREE
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- Helps you feel less hungry between meals**
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- 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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- Promotesdigestive health**
Orange Flavor
48 TABLESPOON DOSES
NET WT 20.3 oz 1.2 LBS (575 g)
Fill controlled by weight, not volume
DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING
*This product is not manufactured or distributed by Procter & Gamble, the distributor of METAMUCIL®.
SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.
Distributed By:
Drug Mart-Food Fair
211 Commerce Dr.
Medina, Ohio 44256
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INGREDIENTS AND APPEARANCE
DISCOUNT DRUG MART ORANGE FLAVOR
psyllium husk natural fiber powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-513 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 12 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C Yellow No. 6 (UNII: H77VEI93A8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) Product Characteristics Color BROWN (Light Yellowish) Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-513-72 575 g in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/16/2019 Labeler - DISCOUNT DRUG MART (047741335)
