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.

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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 older5 capsules, 1 to 3 times a day 
 children 6 to 11 yearsconsider 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

SN1

NATURAL FIBER 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53041-650
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
CARAMEL (UNII: T9D99G2B1R)  
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHELLAC (UNII: 46N107B71O)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Product Characteristics
ColorbrownScoreno score
ShapecapsuleSize20mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53041-650-16100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200301/17/2020
2NDC: 53041-650-75160 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200301/17/2020
3NDC: 53041-650-45320 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200301/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/200301/17/2020
Labeler - Guardian Drug Company (119210276)

Revised: 1/2020
 
Guardian Drug Company