DULCOLAX CHEWY BITES ASSORTED FRUITS- magnesium hydroxide tablet, chewable

Dulcolax Chewy Bites Assorted Fruits by

Drug Labeling and Warnings

Dulcolax Chewy Bites Assorted Fruits 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 Chewy Fruit Bites Saline Laxative

Drug Facts

Active ingredient (in each chew)

Magnesium hydroxide USP 600 mg

Purpose

Saline laxative

Use

● for relief of occasional constipation (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 over 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

● 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 and over: 4 chews (Up to 8 chews)
• children 6 to under 12 years: 2 chews (Up to 4 chews)
• children under 6 years: ask a doctor

Other information

● each chew contains: magnesium 250 mg, sodium 1 mg

● contains FD&C yellow no. 5 (tartrazine) as a color additive

● contains FD&C yellow no. 6

● store at 20°-25°C (68°-77°F)

Inactive ingredients

ammonium hydroxide, carnauba wax, corn syrup, ethanol, ethyl acetate, FD&C blue no. 1, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6, gum arabic, hydrogenated coconut oil, isopropanol, lecithin (soy), natural and artificial flavors, n-butanol, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbitol, sucrose, titanium dioxide, water, white beeswax

Questions?

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

PRINCIPAL DISPLAY PANEL

Dulcolax
Magnesium Hydroxide 600 mg Saline Laxative
Chewy fruit bites
assorted fruit
30 CHEWABLE BITES

INGREDIENTS AND APPEARANCE

DULCOLAX CHEWY BITES ASSORTED FRUITS 
magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0256
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	600 mg

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CORN SYRUP (UNII: 9G5L16BK6N)
ALCOHOL (UNII: 3K9958V90M)
ETHYL ACETATE (UNII: 76845O8NMZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ACACIA (UNII: 5C5403N26O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange, yellow, pink	Score	no score
Shape	ROUND (Ellipsoid)	Size	13mm
Flavor	FRUIT (Lemon, Orange, Strawberry)	Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0256-0	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/06/2022

Labeler - Chattem, Inc. (003336013)