Natural Fiber by Guardian Drug Company Natural Fiber

Natural Fiber by

Drug Labeling and Warnings

Natural Fiber by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL FIBER- psyllium husk capsule 
Guardian Drug Company

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.

----------

Natural Fiber

Active ingredient (in each capsule)

Psyllium husk approx. 0.52 g

Purpose

Fiber laxative

Uses

relieves:

• occasional constipation
• helps restore regularity
• this product generally produces bowel movement in 12-72 hours

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

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

Stop use and ask a doctor if

• you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
• symptoms persist more than 1 week

Keep out of 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 (8oz.) 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. 

• adults and children 12 years and 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

• store at room temperature
• protect contents from moisture.

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 label, including warnings in Drug Facts under peel-back

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

PDP

compare to the active ingredient in Metamucil® capsules

Natural Fiber

100% Natural Psyllium Fiber

Fiber Laxative/Dietary Supplement

Relieves Occasional Constipation

Restores Regularity

100 capsules

NATURAL FIBER 
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-650
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	0.52 g

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
GELATIN (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SHELLAC (UNII: 46N107B71O)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Product Characteristics
Color	brown	Score	no score
Shape	capsule	Size	20mm
Flavor		Imprint Code	G650
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-650-16	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2003	01/17/2020
2	NDC: 53041-650-75	160 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2003	01/17/2020
3	NDC: 53041-650-45	320 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2003	01/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2003	01/17/2020

Labeler - Guardian Drug Company (119210276)

Revised: 1/2020

Document Id: a5f50a6a-d7b1-41b7-8a19-eb77a1205c82

34390-5

Set id: d7b6b576-1b2b-4680-9d07-ffecf344687e

Version: 2

Effective Time: 20200117

 

Guardian Drug Company