OTC Medication Information: GeriCare Docusate Sodium Liquid

GERICARE DOCUSATE SODIUM LIQUID- docusate sodium liquid
GERI-CARE PHARMACEUTICALS, CORP

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.

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses

  • relieves of occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctore before use if you

  • have stomach pain, nausea or vomiting
  • hadve sudden change in bowel habits that persits over a period of 2 weeks
  • are taking mineral oil

Stop use and ask doctor if

  • you have rectal bleeding or fail to have a bowel movement afrer use of this product. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation

If pregnant or breast-feeding, ask a doctor before use

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Directions

shake well before using

  • follow dosing directions below or use as directed by a physician
  • do not exceed recommended dose
  • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in dividend dose
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response

1 teasponnful = 5 mL

Age Dose
Adults and children over 12 years of age 1 to 6 teaspoons (5 mL — 30 mL)
Children under 12 years of age Ask a doctor

OTHER INFORMATION

  • each teaspoonful (5 mL) contains: sodium 9 mg
  • store at room temperature 15°- 30° (59°-86°F)
  • protect from excessive heat
  • Pharmacist-Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP
  • Tamper-Evident: Do not use if foil over bottle opening is torn, broken, or missing

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose

Questions or comments? 1-800-540-3765

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GERICARE DOCUSATE SODIUM LIQUID
docusate sodium liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
METHYLPARABEN
POLOXAMER 124
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM BENZOATE
SODIUM CITRATE
SUCRALOSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-423-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/01/2023
Labeler — GERI-CARE PHARMACEUTICALS, CORP (611196254)

Revised: 03/2023 GERI-CARE PHARMACEUTICALS, CORP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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