NATURAL FIBER THERAPY NATURAL LAXATIVE NATURAL LAXATIVE- psyllium husk powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Bulk-forming Laxative effective in treating occasional constipation and restoring regularity
Authorization status:
OTC monograph not final
Authorization number:
0904-5199-65, 0904-5199-66

NATURAL FIBER THERAPY NATURAL LAXATIVE NATURAL LAXATIVE- psyllium

husk powder, for solution

Major Pharmaceuticals

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.

----------

2688 - Major

Drug Facts

Active ingredient (in each rounded TEASPOON)

Psyllium Husk, approximately 3.4 g

Purpose

Bulk-forming Laxative

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 an allergic reaction in people sensitive to inhaled or ingested

psyllium.

Ask a doctor before use if you have

a sudden change in bowel habits persisting for 2 weeks

abdominal pain, nausea, or vomiting

Stop use and ask a doctor if

constipation lasts more than 7 days

rectal bleeding occurs

These may be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 & childrent 12 years & over: 1 rounded TEASPOON in 8 oz of liquid at the first sign of

irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

children 6 to under 12 years: 1/2 adult dose in 8 oz of liquid, up to 3 times daily.

children under 6 years: consult 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. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as

necessary.

Other information

each teaspoon contains: potassium 30 mg, sodium 5 mg

Store below 30ºC (86ºF).

Protect contents from humidity. Keep tightly closed.

Inactive ingredients

sucrose

Questions or Comments?

(800) 616-2471

DIETARY FIBER SUPPLEMENT

Uses 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

adult dose of this product has 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 yrs. & older: 1 rounded TEASPOON in 8 oz of liquid 3 times daily. Under 12 yrs.:

Ask a doctor. See mixing directions in Drug Facts. 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. See Choking Warnings.

Supplement Facts

Serving Size 1 rounded teaspoon (7g)

Servings Per Container 77

Amount Per Serving %DV**

Calories 25

Total Carbohydrates 7 g 2%

Dietary Fiber 3 g 12%

Soluble Fiber 2 g

Sugars 3 g

Iron 0.4 mg 2%

Sodium 5 mg <1%

Potassium 30 mg <1%

**% Daily Value (DV) is based on a 2,000 calorie diet.

*Daily Value (DV) not established.

INGREDIENTS: Sucrose, Psyllium Husk

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

Re-Order No. 013234

M-29 Rev 08/17

7983-08-17

Uses

effective in treating occasional constipation and restoring regularity

NDC 0904-5199-66

Major®

Fiber Therapy

100% NATURAL PSYLLIUM HUSK FIBER

Bulk Forming Laxative/Dietary Fiber Supplement

ORIGINAL TEXTURE

SEE BACK FOR INFORMATION ABOUT SOLUBLE FIBER AND HEART DISEASE

REGULAR FLAVOR

77 TEASPOON DOSES

NET WT. 19 OZ. (1 LB. 3 OZ. ) (538 g.)

Fill controlled by weight, not volume

NATURAL FIBER THERAPY NATURAL LAXATIVE NATURAL LAXATIVE

psyllium husk powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-519 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PSYLLIUM HUSK (UNII: 0 SHO5340 7G) (PSYLLIUM HUSK - UNII:0 SHO5340 7G)

PSYLLIUM HUSK

3.4 g in 7 g

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

bro wn

S core

S hap e

S iz e

Flavor

Imprint Code

Major Pharmaceuticals

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 0 4-519 9 -6 5

36 8 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 11

0 1/31/20 22

2

NDC:0 9 0 4-519 9 -6 6

538 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 11

0 1/31/20 22

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 8 /0 2/20 11

0 1/31/20 22

Labeler -

Major Pharmaceuticals (191427277)

Revised: 3/2019

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