DOCUSATE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)

Available from:

Olds Softgels Inc.

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 100 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

IMPORTANT This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations.  Olds SoftGels Inc

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM TABLET
OLDS SOFTGELS 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._
----------
Docusate Sodium 50%
IMPORTANT
This is a bulk shipment, intended for further processing only. It is
not to be used in its present condition
and it should be repackaged immediately and labeled strictly in
conformance with the Federal Food,
Drug and Cosmetic Act and other pertinent government regulations.
Keep out of reach of children.
Olds SoftGels Inc
All complaints or claims for allowances of any kind must be made
within 10 days after receipt of goods.
All complaints or claims for allowances of any kind must be made
within 10 days after receipt of goods.
INGREDIENTS: docusate sodium 50% in PEG 400 FD&C red #40 granular,
FD&C yellow #6
granular, gelatin, glycerin, polyethylene glycol 400 USP (PEG 400)
propylene glycol, purified water,
sorbitol special GC
DOCUSATE SODIUM
docusate sodium tablet
PRODUCT INFORMATION
Olds Softgels Inc.
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 16 0 -0 0 2
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)
DOCUSATE SODIUM
10 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
GELATIN (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
SO RBITAN (UNII: 6 O9 2ICV9 RU)
SO RBITO L (UNII: 50 6 T6 0 A25R)
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
no sco re
S HAP E
OVAL
S IZ E
18 mm
FLAVOR
IMPRINT CODE
40 1
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 9 16 0 -0 0 2-0 1
18 0 0 0 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct
0 5/19