DULCOLAX LIQUID- magnesium hydroxide liquid

Dulcolax by

Drug Labeling and Warnings

Dulcolax by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Dulcolax Liquid Saline Laxative - Cherry

Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative

Stimulant-Free

12 Fl Oz (354 mL)

INGREDIENTS AND APPEARANCE

DULCOLAX  LIQUID
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0291
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CHERRY (UNII: BUC5I9595W)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (LIGHT PINK (based on product specifications))	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0291-0	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019

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)