Label: DULCOLAX SOFT CHEWS BLACK CHERRY- magnesium hydroxide tablet, chewable
- NDC Code(s): 41167-0260-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 16, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chew)
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
● 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 take 2 to 4 chews children 6 to under 12 years of age take 1 to 2 chews children 4 to under 6 years of age take 1 chew (single dose or in divided doses) children under 4 years of age ask a doctor
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
DULCOLAX SOFT CHEWS BLACK CHERRY
magnesium hydroxide tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0260 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 Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape RECTANGLE Size 35mm Flavor CHERRY (Black cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0260-0 60 in 1 BAG; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/01/2022 Labeler - Chattem, Inc. (003336013)