Label: DYNAREX LAXATIVE- mineral oil liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 5, 2014
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- Active Ingredient
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
- Keep Out Of Reach Of Children
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
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)