OTC Medication Information: Senna-Lax

SENNA-LAX- sennosides a and b tablet
Preferred Pharmaceuticals Inc.

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.

Drug Facts

Active ingredient

(in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

laxative products for longer than one week unless directed by a doctor

Ask a doctor before use if you have

stomach pain, nausea, or vomiting, noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health care 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

preferable at bedtime or a directed by a doctor
adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
children (6-12 years) 1tablet once a day: maximum 2 tablets once a day
children (2-6 years) ½ tablet once a day: maximum 1 tablet once a day
children under 2 years of age: Ask a doctor

Other information

Store at room temperature, USP
Each tablet contains: Calcium 20 mg

Inactive ingredient

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol

Questions or comments? (800) 616-2471

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Product color may slightly vary due to natural changes of ingredients

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Rev. 10/15

Repackaged By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Senna-Lax

(Standardized Senna Concentrate)

8.6 mg Sennosides

100 Tablets

Senna Lax
(click image for full-size original)
SENNA-LAX
sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6442(NDC:0904-6522)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM SILICATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
LIGHT MINERAL OIL
POLYETHYLENE GLYCOL 400
Product Characteristics
Color BROWN (Mottled brown) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 1122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-6442-3 30 TABLET in 1 BLISTER PACK None
2 NDC:68788-6442-1 100 TABLET in 1 BLISTER PACK None
3 NDC:68788-6442-8 120 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 07/29/2016
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-6442)

Revised: 06/2017 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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