MUCILIN (psyllium- ispaghula husk powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)

Available from:

Paradigm Pharmaceuticals Inc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Fiber therapy for healthy bowel regularity - Treatment of occasional constipation to restore healthy bowel regularity

Authorization status:

OTC monograph not final

Summary of Product characteristics

MUCILIN- PSYLLIUM (ISPAGHULA) HUSK POWDER
PARADIGM 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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MUCILIN ORANGE
ACTIVE INGREDIENT
Psyllium (Ispaghula) husk 2.45 g
PURPOSE
Fiber therapy for healthy bowel regularity
USES
- Treatment of occasional constipation to restore healthy bowel
regularity
WARNINGS
CHOKING: The product should be taken with at least one full glass (8
oz) of liquid.
Without enough liquid it may swell and obstruct throat and esophagus
and cause
choking. If you have difficulty in swallowing do not take this
product. In taking the
product if you feel difficulty in swallowing, breathing problems,
chest pain, vomiting,
seek immediate medical attention.
ALLERGY ALERT: Allergic reactions may occur in those sensitive to
inhaling or ingesting
psyllium husk.
CONSULT A DOCTOR BEFORE USE:
- if you have a sudden change in bowel functions that persists for ten
days or more
- if you suffer from abdominal pain, nausea or vomiting.
DISCONTINUE AND ASK A DOCTOR IF
- your constipation lasts seven days or more
- you experience rectal bleeding
Either of these may be a sign of a serious medical condition.
KEEP OUT OF REACH OF CHILDREN. The product should be administered to
children under
adult supervision; and in case of child overdose.
Contact a physician or a poison control center immediately.
DIRECTIONS
Mix one sachet of Mucilin briskly with at least one full glass (8 oz)
of water or other liquid
such as fruit juice or milk and drink immediately. Take another glass
of fluid. Without
sufficient liquid, the natural swelling of the product may cause
choking. Please see
_WARNINGS_. Do not take the product just before bedtime, or while
lying down.
Adults 12yrs. & older
1 sachet in 8 oz of liquid, may be taken 3 times a day.
Children 6 - 11
yrs.
½ of adult dose may be taken 3 times a day.
Under 6 yrs.
Not recommended, but consu