Senna Syrup

Drug Labeling and Warnings

Drug Details [pdf]

SENNA- sennosides a and b syrup 
Major Pharmaceuticals

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.

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Senna Syrup

Drug Facts

*Senna Syrup is not manufactured or distributed by The Purdue Frederick Company, owners of the registered trademark Senokot®.

Active Ingredient (in each teaspoonful)

Sennosides 8.8 mg

Purpose

Laxative

Uses

relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

Warnings

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• Noticed a sudden change in bowel movements that continues over a period of 2 weeks

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition.

If pregnant or breast-feeding, ask a 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

Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

age	starting dose	maximum dosage
adults and children 12 years and older	2 - 3 teaspoons once a day	3 teaspoons twice a day
children 6 to under 12 years	1 - 1 1/2 teaspoons once a day	1 1/2 teaspoons twice a day
children 2 to under 6 years	1/2 - 3/4 teaspoon once a day	3/4 teaspoon twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• avoid excessive heat
• store at room temperature 15°- 30°C (59°- 86°F)

Inactive ingredients

cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions?

To Report Adverse Drug Event Call (800) 616-2471

Distributed by: MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

MAJOR®

NDC: 0904-6289-09

NEW &
IMPROVED

Senna SYRUP
Natural Vegetable Laxative

For Gentle, Predictable Relief
of Constipation

(standardized extract of senna fruit)

Alcohol Free

Natural Chocolate Flavor

Contents:
8 fl. oz. (237 mL)

•   Compare to active ingredient in
  Senokot ®*

SENNA 
sennosides a and b syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6289
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sennosides A and B (UNII: 1B5FPI42EN) (Sennosides A and B - UNII:1B5FPI42EN)	Sennosides A and B	8.8 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
cocoa (UNII: D9108TZ9KG)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6289-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2012	10/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/23/2012	10/13/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Major Pharmaceuticals		191427277	REPACK(0904-6289)

Revised: 8/2018

Document Id: 08eee169-2274-445d-b34e-99258fcc3507

34390-5

Set id: 4ea8470d-bad9-4257-8222-21cac565e913

Version: 3

Effective Time: 20180807