senna syrup

senna syrup
SPL v4
SPL
SPL Set ID 8b7cc0d5-029b-43f7-a050-8771e7db4551
Route
oral
Published
Effective Date 2024-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides a and b (417.12 mg)
Inactive Ingredients
methylparaben propylene glycol propylparaben water sucrose

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2019-10-25 Until 2024-09-03

Description

Active ingredient (in each 5 ml) purpose Sennosides 8.8 mg …………………………................Laxative


Medication Information

Warnings

Do Not Use • laxative products for longer than 1 week

unless directed by a doctor

Ask a doctor or pharmacist before use if you have

• stomach pain • nausea • vomiting

• notice a sudden change in bowel movement that continues

over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement

after use of laxative. These may indicate a serious condition

If pregnant or breast-feeding, ask a health

professional before use

Uses

relieves occasional constipation (irregularity)

generally causes bowel movement in 6 to 12 hours

Dosage and Administration

Age                                                                   Starting Dose                           Maximum Dose

adults and children                                   12 years 2 - 3 teaspoonfuls         3 teaspoonfuls twice a day

and older once a day



6 years to under 12 years of age              1 - 1½ teaspoonfuls once a day       1½ teaspoonfuls twice a day

2 to under 6 years of age                       ½ - ¾ teaspoon once a day                 ¾ teaspoon once a day

under 2 years of age consult a doctor consult a doctor

Directions

shake well before use

take preferably at bedtime or as directed by a doctor

Other Information
  • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose

Description

Active ingredient (in each 5 ml) purpose Sennosides 8.8 mg …………………………................Laxative

Active Ingredient

Active ingredient (in each 5 ml) purpose

Sennosides 8.8 mg …………………………................Laxative

Principal Panel 

Keep Out of Reach of Children Section

In case of accidental overdose, get medical help or contact a Poison Control Center immediately

Questions?

To Report Adverse Drug Event Call 1(877) 225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179


Structured Label Content

Warnings

Do Not Use • laxative products for longer than 1 week

unless directed by a doctor

Ask a doctor or pharmacist before use if you have

• stomach pain • nausea • vomiting

• notice a sudden change in bowel movement that continues

over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement

after use of laxative. These may indicate a serious condition

If pregnant or breast-feeding, ask a health

professional before use

Uses

relieves occasional constipation (irregularity)

generally causes bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)

Age                                                                   Starting Dose                           Maximum Dose

adults and children                                   12 years 2 - 3 teaspoonfuls         3 teaspoonfuls twice a day

and older once a day



6 years to under 12 years of age              1 - 1½ teaspoonfuls once a day       1½ teaspoonfuls twice a day

2 to under 6 years of age                       ½ - ¾ teaspoon once a day                 ¾ teaspoon once a day

under 2 years of age consult a doctor consult a doctor

Directions

shake well before use

take preferably at bedtime or as directed by a doctor

Other Information
  • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose

Active Ingredient

Active ingredient (in each 5 ml) purpose

Sennosides 8.8 mg …………………………................Laxative

Principal Panel  (PRINCIPAL PANEL )

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

In case of accidental overdose, get medical help or contact a Poison Control Center immediately

Questions?

To Report Adverse Drug Event Call 1(877) 225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179


Advanced Ingredient Data


Raw Label Data

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