Major DOK (Docusate Sodium) 100 mg

DOK by

Drug Labeling and Warnings

DOK by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOK- docusate sodium tablet, film coated 
Major Pharmaceuticals

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.

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Major DOK (Docusate Sodium) 100 mg

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active ingredient (in each tablet)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

For relief of occasional constipation (irregularity).

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

Warnings

Do not use if you are presently taking mineral oil unless told to do so by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use. These could be signs of a serious condition.
• you need to use a laxative product for longer than one week

If pregnant or breast-feeding, ask a doctor before use

Keep out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: take 1 tablet as needed, not to exceed 3 tablets daily, or as directed by a doctor
• Children under 12 years of age: consult a doctoer before use
• Tablets may be swallowed whole or crushed and mixed with food

Other information

• Each tablet contains calcium 40 mg, s odium 10 mg
• Store at room temperature in a dry place

Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic acid

Questions or comments?

Call (800) 616-2471

Distributed by: MAJOR® PHARMACEUTICALS

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, USA

MAJOR ®
NDC: 0904-5869-60
DOK TM
100 MG
(Docusate Sodium)
Stool Softener
For Use as a Stool Softener in Treating and Avoiding Constipation
Crushable Tablets for Ease of Administration
100 TABLETS

DOK 
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5869
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (Round Biconvex)	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5869-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2011	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/21/2011	01/31/2020

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2019

Document Id: 7f6b7829-ee46-7c66-e053-2a91aa0a8f13

34390-5

Set id: 2e44e7a2-5fab-4a8f-8e8e-9c82e3863eab

Version: 3

Effective Time: 20190114

 

Major Pharmaceuticals