PSYLLIUM HUSK FIBER SUPPLEMENT- psyllium husk capsule

Psyllium Husk by

Drug Labeling and Warnings

Psyllium Husk by is a Otc medication manufactured, distributed, or labeled by TIME CAP LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Supplements Facts

• Amount per serving: % DV*
• Total Carb 2 g: <1%*
• Dietary Fiber 2 g: 7%*
• Soluble Fiber 2 g: ††
• Iron 0.4 mg: 2%
• Potassium 25 mg: 1%

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

††Daily Value (DV) not established.

Active ingredient (in each capsule)

Psyllium husk approximately 0.52 g

Purpose

Bulk Forming Laxative

Warnings

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

BEFORE USING this 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.

Bulk-forming fibers like psyllium husk may affect how well medicines work. Take this product at least 2 hours before or after medicines

IMPORTANT INFORMATION

To open bottle, push down and turn
Store in a cool and dry place at temperature below 25°C. Keep container tightly closed to protect from humidity.
Keep out of reach of children

Directions

For adults 12 years and older
HELPS SUPPORT:
DIGESTIVE HEALTH** by promoting regularity	2 to 5 capsules up to 4 times per day	Swallow 1 capsule at a time and take in an upright position
HEART HEALTH†† By lowering cholestrol	5 capsules up to 4 times per day
HEALTHY BLOOD SUGAR LEVELS** take before each meal	5 capsules 4 times per day

††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 1.8 grams of this soluble fiber.

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

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.

NOTICE: Take 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

Other information

• each capsule contains: potassium 5 mg
• capsules are sealed using a band around the middle
• store at room temperature. Keep the container tightly closed to protect from humidity
• contains a 100% natural, therapeutic fiber
• tamper evident: do not use if printed inner seal under cap is broken or missing

INACTIVE INGREDIENT

Ingredients Psyllium husk, gelatin

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

INDICATIONS & USAGE

effective in treating occasional constipation and restoring regularity

This product generally produces bowel movement in 12 to 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSYLLIUM HUSK  FIBER SUPPLEMENT
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-145
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)

Product Characteristics
Color	white (Clear Body with clear cap filled with pale buff to brown granular powder)	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	TCL145
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-145-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2024
2	NDC: 49483-145-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/05/2024

Labeler - TIME CAP LABS INC (037052099)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(49483-145)