Mineral oil by Select Brand Dist. MINERAL OIL oil

Mineral oil by

Drug Labeling and Warnings

Mineral oil by is a Otc medication manufactured, distributed, or labeled by Select Brand Dist.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral oil 100%

Purpose

Intestinal lubricant

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 8 hours

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

Ask a doctor before use if you have

• stomach reflux
• abdominal pain, nausea, or vomiting
• noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

• do not take with meals
• take only at bedtime

Stop use and ask a doctor if

• rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 & children over 12 years: 1 to 3 tablespoons (15 to 45 mL) maximum 3 tablespoons (45 mL) in 24 hours
• children under 12 years: consult a doctor

Other information

• keep tightly closes
• protect from sunlight

Inactive ingredients

d-alpha tocopherol (Vitamin E) as stabilizer

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Extra Heavy

Mineral Oil

Intestinal lubricant

Tasteless Odorless  Colorless

An Effective Intestinal Lubricant for use in the Treatment of Constipation

FL OZ (pt.) mL

Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 710603 USA

AC (870) 535-3635  MADE IN THE U.S.A.

TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP PRINTED SAFETY FOIL IS BROKEN OR MISSING.

Package Label

Select Brand Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-334
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-334-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2009	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	09/25/2009	12/31/2020

Labeler - Select Brand Dist. (012578514)