DYNAREX LAXATIVE- mineral oil liquid 
Dynarex Corporation

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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Dynarex Mineral Oil Laxative

Active Ingredient

Active Ingredient                         Purpose

Mineral oil                                    Intestinal lubricant

Purpose

Purpose

Relieves occassional constipation (irregularity).

Warnings

Warnings

Do not use:

Indications & Usage

Indications & Usage

When using this product 

Ask a doctor before use if you have

Stop use and ask a doctor if

Dosage & Administration

Directions

               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

Other information

Other information

Inactive ingredients

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

Principal Display Panel

Dynarex Mineral Oil Laxative
4270 Min oil.jpg

4270 Mineral oil

DYNAREX LAXATIVE 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-404
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL99 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
Butylated hydroxyanisole (UNII: REK4960K2U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-404-01473 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/05/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Mistair Health & Hygiene Pvt Ltd677604297manufacture(67777-404)

Revised: 3/2014
Document Id: 4b1b8aeb-f368-46a2-8bfd-516e2a1436b9
Set id: a56267f3-2a8b-4a70-9ce5-233ddbf13db6
Version: 1
Effective Time: 20140305
 
Dynarex Corporation