DYNAREX LAXATIVE- mineral oil liquid

DYNAREX LAXATIVE by

Drug Labeling and Warnings

DYNAREX LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Mistair Health & Hygiene Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient                         Purpose

Mineral oil                                    Intestinal lubricant

Purpose

Purpose

Relieves occassional constipation (irregularity).

Warnings

Warnings

Do not use:

• If you have difficulty swallowing.
• In children under 12 years of age.
• If you are pregnant.
• For a period longer than 1 week.
• If you are bedridden or aged.

Indications & Usage

Indications & Usage

• For relief of occassional constipation (irregularity).

When using this product 

• Do not take with meals
• Take only at bedtime

Ask a doctor before use if you have

• Stomach reflux
• Abdominal pain, nausea, or vomiting
• Notice a sudden change in bowel habits that persist over a period of 2 weeks

Stop use and ask a doctor if

• Rectal bleeding or failure to have a bowel movementafter use. These could be signs of a serious condition.

Dosage & Administration

Directions

• Do not take with meals
• Take only at bedtime
• May be taken as a single daily dose or in divided doses.

• age:

  dose

• adults and children over 12 years:

  1 to 3 tablespoons (15 to 45 ml)

  Maximum 3 tablespoons (45ml) in 24 hours

• children under 12 years:

  Consult a doctor

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

• Keep this and all drugs out of the reach of children
• In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other information

Other information

• Keep tightly closed

• Protect from sunlight

Inactive ingredients

Inactive ingredients: Butylated hydroxytoluene (BHT), Butylated hydroxyanisole (BHA)

Principal Display Panel

Dynarex Mineral Oil Laxative
4270 Min oil.jpg

INGREDIENTS AND APPEARANCE

DYNAREX LAXATIVE 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-404
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
butylated hydroxytoluene (UNII: 1P9D0Z171K)
Butylated hydroxyanisole (UNII: REK4960K2U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-404-01	473 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/05/2014

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Mistair Health & Hygiene Pvt Ltd		677604297	manufacture(67777-404)