principal display panel - 10 ml cup tray label

principal display panel - 10 ml cup tray label
SPL v17
SPL
SPL Set ID 557d0f60-9e4b-418e-8a8b-dd93bdf994e2
Route
oral
Published
Effective Date 2023-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Active Ingredient

Docusate sodium 100 mg

Indications and Usage

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

Dosage and Administration

Dose once daily take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

• Sodium content: 14 mg/ 5 mL • Store at controlled room temperature, 20° to 25°C (68° to 77°F) • Protect from freezing • Protect from light • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: NDC 63739-976-01: 10 mL Unit Dose Cup NDC 637369-976-10: 1 case of 100 x 10 mL Unit Dose Cups

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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 stool softener laxative for more than 1 week rash occurs

Section 50569-3

stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

Section 50570-1

if you are presently taking mineral oil, unless told to do so by a doctor

Section 51727-6

artificial cherry vanilla flavoring, citric acid anhydrous, D & C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Section 51945-4

Delivers 10 mL NDC 63739-976-01 Docusate Sodium Liquid 100 mg/ 10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free FOR INSTITUTIONAL USE ONLY Dist. by: SKY Packaging Memphis, TN 38141 SEE DRUG FACTS F0935C101022

Section 53413-1

Call 1-800-845-8210

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Stool softener


Structured Label Content

Active Ingredient (55106-9)

Docusate sodium 100 mg

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Dose once daily take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

• Sodium content: 14 mg/ 5 mL • Store at controlled room temperature, 20° to 25°C (68° to 77°F) • Protect from freezing • Protect from light • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: NDC 63739-976-01: 10 mL Unit Dose Cup NDC 637369-976-10: 1 case of 100 x 10 mL Unit Dose Cups

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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 stool softener laxative for more than 1 week rash occurs

Section 50569-3 (50569-3)

stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

Section 50570-1 (50570-1)

if you are presently taking mineral oil, unless told to do so by a doctor

Section 51727-6 (51727-6)

artificial cherry vanilla flavoring, citric acid anhydrous, D & C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Section 51945-4 (51945-4)

Delivers 10 mL NDC 63739-976-01 Docusate Sodium Liquid 100 mg/ 10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free FOR INSTITUTIONAL USE ONLY Dist. by: SKY Packaging Memphis, TN 38141 SEE DRUG FACTS F0935C101022

Section 53413-1 (53413-1)

Call 1-800-845-8210

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Stool softener


Raw Label Data

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