SHOPRITE ORIGINAL FIBER- psyllium husk powder, for solution
WakeFern Food Corp.

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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ShopRite Original Fiber

Drug Facts

Active Ingredient

Psyllium Hydrophilic Mucilloid 3.4 g

Purpose

Bulk-Forming Laxative

Uses

For relief of occasioinal constipation and to induce regularity. This product generally produces bowel movements within 12-72 hours.

Warnings

Choking Takng this product without adequate fluid may cause ti 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.

Do not use

• when abdominal pain, nausea or vomiting are present unless directed by a doctor
• for more than 1 week unless directed by a doctor
• if you have difficulty swallowing

Ask a doctor before use if you have

• noticed sudden change in bowel habits that persist over a period of 2 weeks.

Stop use and ask a doctor if

•you experience rectal bleeding or fail to have a bowel movement, as 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

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.


adults and children 12 years and older	one teaspoon 1 to 3 times daily
children 6 to under 12 years of age	1/2 teaspoon 1 to 3 times daily
children under 6 years of age	consult a doctor.

Other Information

• each 7g dose contains: Potassium 30mg; Sodium 4 mg; Calcium 8 mg.
• Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before taking other medicines
• tamper-evident bottle mouth sealed for your protection
• do not use if imprinted inner seal is broken or missing
• do not discard into any plumbing system
• store below 86 0 F (30 0C)
• keep container tightly closed-protect from excessive moisture
• can be taken before or after meals, mornings or evenings

Inactive Ingredients

Sucrose

Product Label

Carton

SHOPRITE ORIGINAL FIBER
psyllium husk powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-200
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	0.486 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-200-00	1 in 1 CARTON	06/04/2015	05/01/2020
1		822 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/04/2015	05/01/2020

Labeler - WakeFern Food Corp. (069722418)

Revised: 12/2018

Document Id: 7c4749bb-eb3c-f6bc-e053-2a91aa0a8d0e

Set id: c054b179-5178-4cae-abdb-ed1c41321dc6

Version: 2

Effective Time: 20181205

WakeFern Food Corp.