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

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

Section 55106-9

Docusate sodium 100 mg


Structured Label Content

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

Section 55106-9 (55106-9)

Docusate sodium 100 mg


Raw Label Data

All Sections (JSON)