Fleet Glycerin Laxatives (Fleet)

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COMPOSITION

FLEET® Babylax® Liquid Glycerin Suppositories--Each rectal applicator delivers 2.3 g of glycerin USP.

FLEET® Liquid Glycerin Suppositories for Adults and Children 6 years of age and over--Each rectal applicator delivers 5.6 g of glycerin USP.

FLEET® Maximum-Strength Glycerin Suppositories for Adults--Each suppository contains 3 g of glycerin USP.

FLEET® Glycerin Suppositories for Adults--Each suppository contains 2 g of glycerin USP.

FLEET® Glycerin Suppositories for Children 2 years to under 6--Each suppository contains 1 g of glycerin USP.

ACTIONS AND USES

Glycerin is a hyperosmotic laxative, which is given rectally, and it usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increased bowel action. These products are used for fast, predictable relief of occasional constipation. However, rectal irritation may occur with its use.

GENERAL LAXATIVE WARNINGS

INFORMATION FOR PATIENT

Do not use a laxative product when nausea, vomiting or abdominal pain is present unless directed by a physician. If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a physician. Laxative products should not be used longer than 1 week unless directed by a physician. This product may cause rectal discomfort or a burning sensation.

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

DOSAGE AND ADMINISTRATION

FLEET® Babylax® Liquid Glycerin Suppositories --Children 2 to under 6 years: 1 suppository or as directed by a physician. Children under 2 years: Consult a physician.

Preferred position: Place child on left side with knees bent and arms resting comfortably, or have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

CAUTION: REMOVE ORANGE PROTECTIVE SHIELD FROM TIP BEFORE INSERTING. Hold the unit upright, grasping the bulb with fingers. Grasp the orange protective shield with the other hand; pull gently to remove. With steady pressure, gently insert the tip into the rectum with a slight side-to-side movement, with the tip pointing towards navel. DISCONTINUE USE IF RESISTANCE IS ENCOUNTERED. FORCING THE TIP CAN RESULT IN INJURY. Insertion may be easier if child receiving the liquid suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid has been expelled. While continuing to squeeze the bulb, remove the tip from the rectum and discard the unit. It is not necessary to empty the unit completely. The unit contains more than the amount of liquid needed for effective use. A small amount of liquid will remain in the unit after squeezing.

FLEET® Liquid Glycerin Suppositories for Adults and Children 6 years of age and older: One suppository or as directed by a physician. Children 2 years to under 6 use Fleet® Babylax® Liquid Glycerin Suppositories. Children under 2 years, consult a physician.

Preferred position: Lie on left side with right knee bent and arms resting comfortably, or kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold the unit upright, grasping the bulb with fingers. Grasp the orange protective shield with the other hand; pull gently to remove. With steady pressure, insert the tip into the rectum with a slight side-to-side movement, with the tip pointing toward the navel. DISCONTINUE USE IF RESISTANCE IS ENCOUNTERED. FORCING THE TIP CAN RESULT IN INJURY. Insertion may be easier if person receiving the liquid suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid has been expelled. While continuing to squeeze the bulb, remove the tip from the rectum and discard the unit. It is not necessary to empty the unit completely. The unit contains more than the amount of liquid needed for use. A small amount of liquid will remain in the unit after squeezing.

FLEET® Maximum-Strength Glycerin Suppositories --Adults and Children 6 years of age and older: One suppository.

Remove the foil wrapper and insert one suppository well up into the rectum. The suppository need not melt completely to produce laxative action. Keep away from excessive heat.

FLEET® Glycerin Suppositories --Adults and Children 6 years of age and older: One suppository or as directed by a doctor.

If foil-wrapped, remove the foil wrapper. Insert one suppository well up into the rectum. The suppository need not melt completely to produce laxative action. Store the container tightly closed and keep away from excessive heat.

FLEET® Glycerin Suppositories Child Size --Children 2 to under 6 years: One suppository or as directed by a doctor.

Children under 2 years: Consult a physician.

Insert suppository well up into the rectum. The suppository need not melt completely to produce laxative action. Store the container tightly closed and keep away from excessive heat.

HOW SUPPLIED

FLEET® Babylax® Liquid Glycerin Suppositories for children 2 to under 6 years--Each box contains 6 child rectal applicators (4 mL each).

FLEET® Liquid Glycerin Suppositories for Adults and Children 6 years of age and over--Each box contains 4 adult rectal applicators (7.5 mL each).

FLEET® Maximum-Strength Glycerin Suppositories --Each box contains 18 individually foil-wrapped adult suppositories.

FLEET® Glycerin Suppositories --Available in jars of 12, 24, and 50 adult suppositories as well as a box containing 12 individually foil-wrapped adult suppositories.

FLEET® Glycerin Suppositories Child Size --Available in jars of 12.

IS THIS PRODUCT OTC?

Yes.

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