Psyllium Fiber

Manufacturer
TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:08:17

Label at a glance#

ProductPsyllium Fiber
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Label contents#

Full prescribing information#

Supplement Facts

SPL UNCLASSIFIED SECTION

Serving Size2 rounded tsp (11.6 g)1 rounded tsp (5.8 g)
Servings Per ContainerAbout 36About 72
Amount per Serving% DV*% DV*
Calories3015
Total Carbonate10g4%*5 g2%*
Dietary Fiber6 g21%*3 g11%*
Soluble Fiber5 g††2 g††
Iron0.8 mg4%0.4 mg2%
Sodium10 mg<1%5 mg<1%
Potassium70 mg1%35 mg1%

*Percent Daily Values (%DV) are based on a 2,000 calorie diet.

†† Daily Value (DV) not established.

INACTIVE INGREDIENT SECTION

INGREDIENTS: aspartame powder, citric acid monohydrate, colloidal silicon dioxide, FD&C yellow no. 6, maltodextrin, orange flavor, psyllium husk

WARNINGS SECTION

ALLERGY ALERT: This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.

NOTICE: Mix this product with at least 8 oz (a full glass) of liquid. Taking without enough liquid may cause choking. Do not take if you have difficulty swallowing.

IMPORTANT INFORMATION:

PHENYLKETONURICS: CONTAINS PHENYLALANINE, 30 mg per teaspoon
Store below 86°F (30° C). Keep container tightly closed to protect from humidity.
Keep out of reach of children

NEW USERS: Start with one serving per day; gradually increase to desired daily intake. You may experience changes in bowel habits/ minor bloating, as your body adjusts to increased fiber intake. Bulk-forming fibers like psyllium husk may affect how well medicines work. Take this product at least 2 hours before or after medicines.

BEFORE USINGthis dietary supplement ask your doctor if you

are considering using this product as part of a cholesterol lowering program
are using medication to control your blood sugar levels
have recently experienced abdominal pain, nausea, vomiting or a sudden change in bowel habits persisting for two weeks

STOP USING this dietary supplement and ask a doctor if constipation lasts more than 7 days or rectal bleeding occurs. These may be signs of a serious condition.

DOSAGE & ADMINISTRATION SECTION

HOW TO TAKE THIS PRODUCT

(For adults 12 years and older)

1. Put 1-2 rounded teaspoons in empty glass.

2. Mix briskly with 8 oz or more of cool liquid.

3. Drink promptly and enjoy!

HOW MUCH TO TAKE

The psyllium husk fiber in this product helps support:

DIGESTIVE HEALTH** by promoting regularity

HEART HEALTH†† by lowering cholesterol

HEALTHY BLOOD SUGAR LEVELS** take before each meal

1 ROUNDED TEASPOONS up to 3 times per day

OR

APPETITE CONTROL** take before each meal

2 ROUNDED TEASPOONS up to 3 times per day

** THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

††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 has 2.4 grams of this soluble fiber.

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-877-290-4008

OTC - PURPOSE SECTION

Fiber Laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

psyllium-husk-powder-15oz-labelpsyllium-husk-powder-15oz-label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-73949483-739-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28ad330f-907d-1aae-e063-6294a90aa12613ad59f6-cc9d-d4d1-e063-6294a90ab2902024-12-07WarningsExact identifier
spl set id: 13ad59f6-cc9d-d4d1-e063-6294a90ab290

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.