Label: DOCUSATE SODIUM- docusate sodium liquid
- NDC Code(s): 55154-9401-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0121-0544
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Each 5 ml (teaspoonful) contains docusate sodium 50 mg.Close
Stool Softener LaxativeClose
- Keep Out of Reach of Children
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.Close
For relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.Close
Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement after the use of a laxative may indicate a serious condition. Discontinue use and consult you physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.
DRUG INTERACTION PRECAUTION: Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.Close
As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1/2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.Close
- Inactive ingredients
Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
Sodium Content: 14 mg/5 mlClose
For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.Close
- Drug Interaction Precaution
Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.Close
- How Supplied
Purple colored, cherry flavored liquid supplied in the following oral dosage forms: NDC 0121-0544-10
(unit dose cups of 10 mL, 10 x 10's), NDC 0121-0544-25
(unit dose cups of 25 mL, 10 x 10's), and NDC 0121-0544-16
(16 fl oz bottle).Close
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Pharmaceutical Associates, Inc.
Greenville, SC 29605
- Principal Display Panel
Docusate Sodium Liquid
100 mg/10 ml
Stool Softener Laxative
5 Unit Dose Cups
- INGREDIENTS AND APPEARANCE
docusate sodium liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-9401(NDC:0121-0544) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg in 10 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE D&C RED NO. 33 GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL Product Characteristics Color PURPLE Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-9401-5 5 in 1 BAG 1 10 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/02/2011 Labeler - Cardinal Health (188557102) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK