Label: DOCUSATE SODIUM liquid
- NDC Code(s): 48433-220-10
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 54859-813
- 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 January 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each 5 mL = 1 teaspoonful)
- Purpose
- Use:
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WARNINGS:
Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor
Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil
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DOSAGE & ADMINISTRATION
Directions:
* Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
* Shake well before using
* Do not exceed recommended dose
* May be taken in one to four equally divided oral doses each day
* Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual responseAdults and children 12 years of age and over 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor Children 6 to 12 years of age 4 mL to 15 mL (3 teaspoons) or as directed by a doctor Children 3 to 6 years of age 2 mL to 6 mL or as directed by a doctor Children under 3 years of age 1 mL to 4 mL or as directed by a doctor 1 teaspoon = 5 mL
Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions
between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified
water, sodium benzoate, sodium citrate, and sucralose.NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup
Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN54733 4843322010 8
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Principal Display Panel - Box Label
SAFECOR
HEALTH
Docusate Sodium Liquid
100 mg / 10 ml
Contains 40 (10 ml) Unit Dose CupsSee monograph for complete drug information.
NDC: 48433-220-40
QTY: 40
Lot: 21A0079
Exp: 2023-03-31Store at room temperature 20°C-25°C (68°F-77°F);
excursions between 15°C-30°C (59°F-86°F) are allowed.
Protect from excessive heat. Protect from light.
This package design is not child resistant. For institutional use only.
Shake well before use.3 48433 22040 5
Pkg By: Safecor Health, LLC Columbus, OH 43204
Questions or Comments: Call 1-800-447-1006GTIN: 00348433220405
SN: 212802331
Exp; 2023-03-31
Lot 21A0079 PN5689.C
- Principal Display Panel - Lid Label
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-220(NDC:54859-813) 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 in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 124 (UNII: 1S66E28KXA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-220-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2021 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 828269675 repack(48433-220)
