DOCUSATE SODIUM 100mg Two-Tone description, usages, side effects, indications, overdosage, supplying and lots more!

DOCUSATE SODIUM 100mg Two-Tone

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor 
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor                                       

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you  fail to have a bowel movement after use

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.

Directions

take with a glass of water

Adults and children 12 years of ages and over

take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 and under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules
NDC. No : 53345-018-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM 100mg Two-Tone

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-018
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
D&C RED NO. 33
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol
ANHYDROUS CITRIC ACID

Product Characteristics

Color Size Imprint Code Shape
white (Two-Tone) 13 mm PC18 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20000 in 1 BAG
2 NDC:53345-018-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-12-23


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Be sure to consult your doctor before taking any medication!
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