OTC Medication Information: Dulcolax Liquid

DULCOLAX LIQUID- magnesium hydroxide liquid
Chattem, Inc.

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.

Dulcolax®

Liquid Saline Laxative – Cherry

Drug Facts

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Use

for relief of occasional constipation and irregularity

this product generally produces bowel movement in ½ to 6 hours

Warnings

Ask a doctor before use if you have

kidney disease

● a magnesium-restricted diet

● stomach pain, nausea or vomiting

● noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

taking a prescription drug. This product may interact with certain prescription drugs.

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.

you need to use a laxative for more than 1 week

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 right away.

Directions

shake well immediately before each use

● for accurate dosing, use convenient pre-measured dose cup

● drink a full glass (8 oz) of liquid with each dose

● dose may be taken as a single daily dose or in divided doses

● do not exceed the maximum recommended daily dose in a 24 hour period

adults and children 12 years of age and over 30 mL to 60 mL

children 6 to under 12 years of age 15 mL to 30 mL

children 2 to under 6 years of age 5 mL to 15 mL

children under 2 years of age ask a doctor

Other information

each 15 mL contains:

calcium 20 mg, magnesium 595 mg, potassium 5 mg, sodium 3 mg

● do not use if safety seal is broken or missing

● close cap tightly after each use

● store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol, sucrose, xanthan gum

Questions?

Call 1- 866-844-2798 or visit www.Dulcolax.com

PRINCIPAL DISPLAY PANEL

Stimulant-Free
Dulcolax
Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative
Liquid
Cherry Flavor

12 Fl Oz (354 mL)

Stimulant-Free
Dulcolax 
Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative
Liquid
Cherry Flavor
12 Fl Oz (354 mL)
(click image for full-size original)
DULCOLAX LIQUID
magnesium hydroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0291
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 1200 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 28
CHERRY
GLYCERIN
WATER
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color pink (LIGHT PINK (based on product specifications)) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0291-0 354 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/01/2019
Labeler — Chattem, Inc. (003336013)

Revised: 06/2021 Chattem, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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