Safecor Health

Safecor Health
SPL v4
SPL
SPL Set ID e1dca0d6-6e6e-4ba2-a7b8-009aeb00ef63
Route
ORAL
Published
Effective Date 2020-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.8 mg)
Inactive Ingredients
Methylparaben Propylene Glycol Propylparaben Water Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Active Ingredient (in each 5 mL = 1 teaspoonful) Sennosides 8.8 mg


Medication Information

Warnings and Precautions

WARNINGS: Do not use • laxative products for a period longer than 1 week unless directed by a doctor

Indications and Usage

Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.

Dosage and Administration
1 teaspoonful = 5 mL
Directions:
  • Shake well before use
  • Do not exceed recommended dose
Age Starting Dose Maximum Dosage
Adults and children 12 years of age and over 2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
Children under 12 years of age Ask a doctor Ask a doctor
Description

Active Ingredient (in each 5 mL = 1 teaspoonful) Sennosides 8.8 mg

Section 42229-5

NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204                                                               Rev: 02/2020 PN5497

Section 44425-7

Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if you have • rectal bleeding • no bowel movement after use of laxative

These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movement that continues over a period of 2 weeks

Section 51727-6

Inactive ingredients: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.

Section 51945-4

———Principal Display Panel———

SAFECOR HEALTH

                                                                              NDC: 48433-219-40

Senna Syrup                                                         Qty: 40

8.8 mg Sennosides per 5 mL                                 Lot: 20A0020


Contains 40 (5 mL) Unit Dose Cups                      Exp: 210203

See monograph for complete drug information.

Store at room temperature 15°C to 25°C (59°F to 77°F);

excursions between 26°C to 30°C (78°F to 86°F) are allowed.

Protect from excessive heat.

This package design is not child resistant. For institutional use only.

Shake well before use.

                                                                                     GTIN: 00348433219409

                                                                                     SN: 200600019


Pkg By: Safecor Health, LLC Columbus, OH 43204   Exp: 210203

     Questions or Comments: Call 1-800-447-1006       Lot: 20A0020

Section 53414-9

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

Section 55105-1

Purpose

Laxative

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Sennosides 8.8 mg


Structured Label Content

Indications and Usage (34067-9)

Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.

Dosage and Administration (34068-7)
1 teaspoonful = 5 mL
Directions:
  • Shake well before use
  • Do not exceed recommended dose
Age Starting Dose Maximum Dosage
Adults and children 12 years of age and over 2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
Children under 12 years of age Ask a doctor Ask a doctor
Warnings and Precautions (34071-1)

WARNINGS: Do not use • laxative products for a period longer than 1 week unless directed by a doctor

Section 42229-5 (42229-5)

NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204                                                               Rev: 02/2020 PN5497

Section 44425-7 (44425-7)

Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have • rectal bleeding • no bowel movement after use of laxative

These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movement that continues over a period of 2 weeks

Section 51727-6 (51727-6)

Inactive ingredients: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.

Section 51945-4 (51945-4)

———Principal Display Panel———

SAFECOR HEALTH

                                                                              NDC: 48433-219-40

Senna Syrup                                                         Qty: 40

8.8 mg Sennosides per 5 mL                                 Lot: 20A0020


Contains 40 (5 mL) Unit Dose Cups                      Exp: 210203

See monograph for complete drug information.

Store at room temperature 15°C to 25°C (59°F to 77°F);

excursions between 26°C to 30°C (78°F to 86°F) are allowed.

Protect from excessive heat.

This package design is not child resistant. For institutional use only.

Shake well before use.

                                                                                     GTIN: 00348433219409

                                                                                     SN: 200600019


Pkg By: Safecor Health, LLC Columbus, OH 43204   Exp: 210203

     Questions or Comments: Call 1-800-447-1006       Lot: 20A0020

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Laxative

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Sennosides 8.8 mg


Advanced Ingredient Data


Raw Label Data

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