Label: LAXACIN tablet
- Label RSS
- Share
- NDC Code(s): 61919-497-60
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 50488-0901
- Category: HUMAN OTC DRUG LABEL
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 March 26, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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 doctorAsk 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 weeksStop 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.
- OVERDOSAGE
-
DOSAGE & ADMINISTRATION
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 dayOther 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 - DO NOT USE
- DO NOT USE
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
-
DOSAGE & ADMINISTRATION
Directions
•
take preferably at bedtime or as directed by a doctorage
starting dose
maximum dose
adults and children 12
years and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years
1/2 tablet once a day
1 tablet twice a day
children under 2 years
ask a doctor
ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LAXACIN
laxacin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-497(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 MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) DEXTROSE (UNII: IY9XDZ35W2) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 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:61919-497-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/26/2018 Labeler - DIRECT RX (079254320) Registrant - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-497)
