Label: DOCUSATE SODIUM- docusate sodium liquid 

  • Label RSS
  • 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.

Drug Label Information

Updated 06/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Each 5 ml (teaspoonful) contains docusate sodium 50 mg.

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  • Purpose

    Stool Softener Laxative

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  • 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.

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  • Uses

    For relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

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  • Warnings

    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.

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  • Directions

    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.

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  • Inactive ingredients

    Sugar Free

    Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

    Sodium Content: 14 mg/5 ml

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  • Indications

    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.

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  • Drug Interaction Precaution

    Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

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  • 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).

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  • Storage

    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

    R01/01

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  • Principal Display Panel

    Docusate Sodium Liquid

    100 mg/10 ml

    Stool Softener Laxative

    5 Unit Dose Cups

    bag label
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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    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
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