FIBER LAXATIVE- psyllium husk capsule

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

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Active ingredient:
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)
Available from:
Raritan Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Fiber laxative
Authorization status:
OTC monograph not final
Authorization number:
68163-119-25

FIBER LAXATIVE- psyllium husk capsule

Raritan Pharmaceuticals Inc

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.

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DRx Choice Fiber Capsules Natural Psyllium Husk

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approximately 0.52 g

Purpos e

Fiber laxative

Us es

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

Stop use and ask a doctor if

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 at 1-800-222-1222.

Directions

effective in treating occasional constipation and restoring regularity

a sudden change in bowel habits persisting for 2 weeks

abdominal pain, nausea or vomiting

constipation lasts more than 7 days

rectal bleeding occurs

Other information

WARNING: Consuming this product can expose you to chemicals including lead, which is known

to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

Inactive ingredients

caramel color, edible ink, gelatin, polysorbate 80

PRINCIPAL DISPLAY PANEL - 25 Capsules Label

NDC 68163-119-25

Compare to the active ingredient in Metamucil

Capsules 3 in 1 MultiHealth Fiber!™*

100% Natural Psyllium Husk

Fiber Capsules

Fiber Laxative/Dietary Supplement

†See back for information about soluble fiber and heart disease

25 Capsules

Mfg. by: Raritan Pharmaceuticals

8 Joanna Court

East Brunswick, NJ 08816

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil®

Capsules 3 in1 MultiHealth Fiber!™.

Take this product 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.

Adults 12 years and older: 5 capsules with at least 8 ounces. of liquid (swallow 1 capsule at a

time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in

12-72 hours

children 12 years and under: Ask a doctor

Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a

prescription medication 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.

each capsule contains: potassium 5 mg

store at room temperature. Keep tightly closed to protect from humidity

contains a 100% natural, therapeutic fiber

®

Helps maintain healthy blood sugar levels as part of your diet**

Helps lower cholesterol to promote heart health†

Promotes digestive health**

Gluten free (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you

should consult your doctor before consuming this product.

FIBER LAXATIVE

psyllium husk capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 16 3-119

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

0 .52 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARAMEL (UNII: T9 D9 9 G2B1R)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Raritan Pharmaceuticals Inc

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

CAPSULE

S iz e

21mm

Flavor

Imprint Code

RP119

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 16 3-119 -25

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

0 4/16 /20 19

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 4/16 /20 19

Labeler -

Raritan Pharmaceuticals Inc (127602287)

Revised: 8/2020

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