Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 87188d31-9fb1-5681-e053-2a91aa0a3022
Route
ORAL
Published
Effective Date 2019-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (2168 mg) Senna Pods (496 mg)
Inactive Ingredients
Levomenthol Anhydrous Lactose

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-04-22

Description

psyllium husk powder, sennae fructus powder


Medication Information

Warnings and Precautions

do not administer to the following patients,

the product contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp deficiency or glucose-galactose malabsorption should not take this medicine

Indications and Usage

adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

Dosage and Administration

for oral use only

Description

psyllium husk powder, sennae fructus powder

Section 50565-1

keep out of reach of the children

Section 51727-6

lactose monohydrate, acacia, corn starch, carboxymethylcellulose calcium, l-menthol

Section 51945-4

Section 55105-1

constipation

relieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids

Section 55106-9

psyllium husk powder, sennae fructus powder


Structured Label Content

Indications and Usage (34067-9)

adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

Dosage and Administration (34068-7)

for oral use only

Warnings and Precautions (34071-1)

do not administer to the following patients,

the product contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp deficiency or glucose-galactose malabsorption should not take this medicine

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

lactose monohydrate, acacia, corn starch, carboxymethylcellulose calcium, l-menthol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

constipation

relieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids

Section 55106-9 (55106-9)

psyllium husk powder, sennae fructus powder


Advanced Ingredient Data


Raw Label Data

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