Label: PROMOLAXIN- docusate sodium tablet
- NDC Code(s): 35356-822-00, 35356-822-60
- Packager: Lake Erie Medical DBA Quality Care Products LLC
- This is a repackaged label.
- Source NDC Code(s): 27495-012
- 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 June 6, 2013
If you are a consumer or patient please visit this version.
- Active ingredient
Docusate Sodium 100 mgClose
- for relief of occasional constipation (irregularity). This product generally produces a bowel movement within 12 to 72 hours.
- Do not use
- laxative products for longer than one week unless directed to do so by a doctor
- if you are presently taking mineral oil unless told to do so by a doctor
- Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use
These could be signs of a serious condition.
- If pregnant or breast-feeding,
ask a doctor before use.Close
- Keep out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
Adults and children 12 years of age and older:
Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.
Children under 12 years of age:
Consult a doctor before use.Close
- Other information
- Each tablet contains: Calcium 40 mg
- Each tablet contains: Sodium 10 mg
- Store at room temperature.
- Do not use if imprinted safety seal is broken or missing.
- Inactive ingredients
Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.Close
If you have any questions or comments, or to report an adverse event,
please contact 714-875-6316.
Manufactured for: Physician's Science and Nature, Inc.
220 Newport Center Drive 11-634, Newport Beach, CA 92660Close
- Image of Label
- INGREDIENTS AND APPEARANCE
docusate sodium tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35356-822(NDC:27495-012) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code GPI;S1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35356-822-60 60 in 1 BOTTLE 2 NDC:35356-822-00 00 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/15/2011 Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) Establishment Name Address ID/FEI Business Operations Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(35356-822) , relabel(35356-822)