DOCUSATE: 2,620 Adverse Event Reports & Safety Profile

Prolaxa™ PROLAXA™ Stool Softener DOCUSATE SODIUM, 250 mg STOOL SOFTENER LAXATIVE - SOFTGELS MAXIMUM STRENGTH Easy to swallow Relieves constipation Gentle Relieve Dependable Stimulant Free TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Uses

• For the relief of occasional constipation.
• Helps to prevent dry, hard stools.
• This product generally produces a bowel movement within 12 to 72 hours.

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 response 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 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 PN5473 3 4843322010 8

Warnings Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have
• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active ingredients Purpose (in each tablet)

Purpose

Docusate sodium 50 mg.......................................Stool softner Sennosides 8.6 mg................................................Laxative

Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52504