OTC Medication Information: Docusate Sodium

DOCUSATE SODIUM- docusate sodium capsule
PD-Rx Pharmaceuticals, Inc.

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use if you are presently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea or vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years of age ask a doctor

Other information

  • Tamper Evident: Do not use if seal is broken or missing from bottle
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F).

keep tightly closed.

Inactive ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

Docusate

Sodium

55289493 Label
(click image for full-size original)
DOCUSATE SODIUM
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55289-493(NDC:16103-399)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL
TITANIUM DIOXIDE
D&C RED NO. 33
Product Characteristics
Color red (Two-toned- white and clear red) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code SCU2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-493-12 12 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:55289-493-14 14 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:55289-493-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
4 NDC:55289-493-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
5 NDC:55289-493-90 90 CAPSULE in 1 BOTTLE, PLASTIC None
6 NDC:55289-493-93 180 CAPSULE in 1 BOTTLE, PLASTIC None
7 NDC:55289-493-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M007 03/01/2016
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-493)

Revised: 03/2024 PD-Rx Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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