Label: LAXACIN- docusate sodium and sennosides tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-4985-0 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 50488-0901
- 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.
Drug Label Information
Updated July 12, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These may indicate a serious condition.If pregnant or breast feeding, ask a health professional before use.
- Keep Out of Reach of Children
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Directions
- take preferably at bedtime or as directly by a doctor
age starting dose maximum dose adults and children 12 years and older 2 tablets once a day 4 tablets twice a day Other information
- Each tablet contains: Calcium 20 mg
- Each tablet contains: Sodium 4 mg
- Store at room temperature
- Keep lid tightly closed in a dry place
- Do not use if imprinted safety seal under cap is broken or missing
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Inactive ingredients
Croscarmellose Sodium, D&C Yellow #10, Dextrose, Dicalcium Phosphate, FD&C Yellow #6, Hypromelose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.
Questions? If you have any questions or comments, or to report an adverse event, please contact (480) 253-9761.
Manufactured for:
Alexso Inc.
Thousand Oaks, CA 91360 - Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
LAXACIN
docusate sodium and sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-4985(NDC:50488-0901) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DEXTROSE (UNII: IY9XDZ35W2) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code G55 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-4985-0 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/01/2011 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-4985) , repack(68258-4985)
