FDA Label for Docusate Sodium
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOONFUL)
- PURPOSE
- USE:
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL - BOX LABEL
- PRINCIPAL DISPLAY PANEL - LID LABEL
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Safecor Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml = 1 Teaspoonful)
Docusate Sodium 50 mg
Purpose
Stool Softener
Use:
Relief of occasional constipation
Otc - Do Not Use
Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor
Otc - Ask 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
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days.
These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.
Dosage & Administration
Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation | |
| Adults 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 Safety Information
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 Ingredient
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 PN5473
3 4843322010 8
Principal Display Panel - Box Label
SAFECOR
HEALTH
Docusate Sodium Liquid
100 mg / 10 ml
Contains 40 (10 ml) Unit Dose Cups
See monograph for complete drug information.
NDC: 48433-220-40
QTY: 40
Lot: 21A0079
Exp: 2023-03-31
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.
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 1-800-447-1006
GTIN: 00348433220405
SN: 212802331
Exp; 2023-03-31
Lot 21A0079 PN5689.C
Principal Display Panel - Lid Label
Delivers 10 mL
NDC 48433-220-10
Docusate
Sodium Liquid
100 mg/10mL
SHAKE WELL
348433220108
Pkg By: Safecor Health, LLC
Columbus, OH 43204
PN5618.B
* Please review the disclaimer below.