Stool Softener: Package Insert and Label Information

STOOL SOFTENER- docusate sodium capsule, liquid filled
NuCarePharmaceuticals, Inc.

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.

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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.

Directions

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

Package Label

STOOL SOFTENER docusate sodium capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3048(NDC:57896-401) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg

Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL

Product Characteristics Color red (reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-3048-4 40 CAPSULE, LIQUID FILLED in 1 BOTTLE None 2 NDC:68071-3048-6 60 CAPSULE, LIQUID FILLED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000

Labeler — NuCarePharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals, Inc.		010632300	repack (68071-3048)

Revised: 02/2021 NuCarePharmaceuticals, Inc.