Label: DULCOLAX CHEWY BITES ASSORTED FRUITS- magnesium hydroxide tablet, chewable
- NDC Code(s): 41167-0256-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 3, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chew)
- Purpose
- Use
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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.
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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
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DULCOLAX CHEWY BITES ASSORTED FRUITS
magnesium hydroxide tablet, chewableProduct 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)