NATURAL FIBER FIBER LAXATIVE/DIETARY SUPPLEMENT- psyllium husk capsule 
American Health Packaging

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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Natural Fiber

Fiber Laxative/Dietary Supplement



8297332/0915OS

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approx. 0.52 g

Purpose

Fiber laxative

Uses

relieves:

  • occasional constipation
  • helps restore regularity
  • promotes normal function of the bowel

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.

Ask a doctor before use if you have

  • abdominal pain, nausea or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks

Allergy alert:

this product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

Stop use and ask a doctor if

  • you fail to have a bowel movement after use
  • rectal bleeding occurs
  • symptoms persist more than 1 week

Keep out of the reach of children.

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

Directions

  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • swallow capsules one at a time
  • daily maximum 3 doses
  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation
  • product generally produces effect in 12 – 72 hours.

adults and children 12 years & older

5 capsules, 1 to 3 times a day

children 6 to 11 years

consider use of powder form of product

children under 6 years

ask 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.

Other information

  • for your protection do not use product if blister is torn or broken
  • store at room temperature
  • protect contents from moisture
  • Supplied as unit dose packages of 20 (5 x 4) NDC 68084-973-32

Inactive ingredients

caramel color, gelatin, iron oxide, polysorbate 80, shellac.

Fiber Supplement Information

Uses

An easy way to increase your daily fiber intake. 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 provides 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 package insert, including warnings in Drug Facts.

Directions

Adults 12 yrs. & older: 2-6 capsules for increasing daily fiber intake; 6 capsules for cholesterol lowering use. Take this product with 8 oz. of liquid (swallow 1 capsule at a time) up to 3 times daily. NOTICE: Take this product with at least 8 oz. (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing.

 

Supplement Facts

To report a serious adverse event contact American Health Packaging at: 1-800-707-4621.

PACKAGING INFORMATION

American Health Packaging unit dose blisters contain drug/supplement product from AmerisourceBergen distributed for Good Neighbor Pharmacy® as follows:
(0.52 g / 20 UD) NDC 68084-973-32 packaged from NDC 46122-100

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, Ohio 43217

8297332/0915OS

Principal Display Panel - Carton

Natural Fiber (Fiber Laxative/ Dietary Supplement) carton label

NDC 68084-973-32

Natural Fiber

Fiber Laxative/
Dietary Supplement

20 Capsules (5 x 4)

To report a serious adverse event, contact American Health
Packaging at: 1-800-707-4621. The drug product contained in
this package is from NDC # 46122-100, AmerisourceBergen
distributed for Good Neighbor Pharmacy®.

Distributed by: American Health Packaging, 2550 John Glenn
Avenue, Suite A, Columbus, Ohio 43217

097332
Rev. 09/2015OS

NATURAL FIBER  FIBER LAXATIVE/DIETARY SUPPLEMENT
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-973(NDC:46122-100)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK0.52 g
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARAMEL (UNII: T9D99G2B1R)  
SHELLAC (UNII: 46N107B71O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorbrownScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code G;650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68084-973-3220 in 1 BOX, UNIT-DOSE11/02/201511/30/2017
1NDC:68084-973-331 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/01/201511/30/2017
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(68084-973)

Revised: 7/2017
Document Id: 559d7aba-7b01-6e08-e054-00144ff88e88
Set id: ffe30caf-8ffc-48e4-8721-86e326405d79
Version: 3
Effective Time: 20170731
 
American Health Packaging