PSYLLIUM FIBER POWDER- psyllium husk powder

Psyllium Fiber Powder by

Drug Labeling and Warnings

Psyllium Fiber Powder by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Supplement Facts

Serving Size	2 rounded tsp (24 g)		1 rounded tsp (12 g)
Servings Per Container	About 57		About 114
Amount per Serving		% DV*		% DV*
Calories	77		39
Total Cabonate	23 g	8%*	12 g	4%*
Dietary Fiber	6 g	21%*	3 g	11%*
Soluble Fiber	5 g	†	3 g	†
Total Sugars	16 g	†	8 g	†
Includes Added Sugars	16 g	32%*	8 g	16%*
Iron	0.7 mg	4%	0.4 mg	4%
Sodium	10 mg	<1%	5 mg	<1%
Potassium	66 mg	2%	33 mg	1%

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

†Daily Value (DV) not established.

INACTIVE INGREDIENT

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

WARNINGS

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:

• 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.

If you have specific dietary needs, you should consult your doctor before consuming this product. This product has a low glycemic index a measure of the effect of dietary carbohydrates on blood sugar levels.

DOSAGE & ADMINISTRATION

HOW TO TAKE THIS PRODUCT

(For adults 12 years and older)

1. Put 1-2 rounded tablespoons 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 TABLESPOON up to 3 times per day

OR

APPETITE CONTROL**take before each meal

2 ROUNDED TABLESPOONS 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.

QUESTIONS

Questions or comments?
Call 1-800-910-6874

PURPOSE

Fiber Laxative

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSYLLIUM FIBER POWDER 
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-348
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
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	white (White to light brown)	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-348-02	1360 g in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	06/15/2024

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(11673-348)