4718 ENEMA, MINERAL OIL- 4718 enema, mineral oil enema
Dynarex

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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4718 Enema, Mineral Oil 67777-430-01

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant Laxative

Uses

For relief of occasional constipation.
This product generally produces bowel movement in 2 to 15 minutes.

Warnings

For rectal use only.

Do not use

Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
Longer than one week unless directed by a doctor.

Ask a doctor before use if you have

Noticed a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor if

You have rectal bleeding or fail to have a bowel movement after use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years old and older: 1 bottle daily.
Children from 2 to under 12 years of age: 1/2 bottle once daily.
Children under 2 years old: Consult a doctor.

Other information

Store at room temperature.

Questions?

1-888-Dynarex

Label

4718 Enema Box Label Enema, Mineral Oil, 4718

4718 ENEMA, MINERAL OIL
4718 enema, mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67777-430
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	133 g in 133 mL

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-430-01	48 in 1 CASE	02/26/2021
1	NDC:67777-430-02	1 in 1 BOX
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/26/2021

Labeler - Dynarex (008124539)