LAXATIVES RUBILAX- psyllium huskpowder granule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G), SENNA PODS (UNII: S8SJ19N2NX) (SENNA PODS - UNII:S8SJ19N2NX)
Available from:
Lydia Co., Ltd.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
constipation relieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids 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
Authorization status:
unapproved drug other
Authorization number:
72988-0010-1, 72988-0010-2

LAXATIVES RUBILAX- psyllium huskpowder granule

Lydia Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

psyllium husk powder, sennae fructus powder

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

constipation

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

fermentation, hemorrhoids

keep out of reach of the children

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

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

for oral use only

LAXATIVES RUBILAX

psyllium huskpowder granule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 8 8 -0 0 10

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PSYLLIUM HUSK (UNII: 0 SHO5340 7G) (PSYLLIUM HUSK - UNII:0 SHO5340 7G)

PSYLLIUM HUSK

216 8 mg in 3.5 g

SENNA PO DS (UNII: S8 SJ19 N2NX) (SENNA PODS - UNII:S8 SJ19 N2NX)

SENNA PODS

49 6 mg in 3.5 g

Lydia Co., Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

LEVO MENTHO L (UNII: BZ1R15MTK7)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 8 8 -0 0 10 -2

30 in 1 POUCH

0 4/22/20 19

1

NDC:729 8 8 -0 0 10 -1

3.5 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 4/22/20 19

Labeler -

Lydia Co., Ltd. (695735569)

Registrant -

Lydia Co., Ltd. (695735569)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

I Wo rld Pharmaceutical Co ., Ltd.

6 8 8 2228 57

ma nufa c ture (729 8 8 -0 0 10 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lydia Co ., Ltd.

6 9 573556 9

la be l(729 8 8 -0 0 10 )

Revised: 4/2019

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