OTC Medication Information: SennaLax-S

SENNALAX-S- docusate sodium and sennosides tablet, film coated
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.

Active ingredients (in each tablet)

Docusate sodium, 50 mg
Sennosides, 8.6 mg

Purpose

Stool Softener
Stimulant laxative

Uses

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

Warnings

Do not use

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition.

If pregnant or breast-feeding, ask a health 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

age

starting dose

maximum dosage

adults & children 12 years and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other information

each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
do not use if imprinted safety seal under cap is missing or damaged.
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
keep tightly closed.

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

colloidal silicon dioxide, D&C yellow No. 10, dicalcium phosphate, ethanol, FD&C yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide.

Mfg. for:
Qualitest Pharmaceuticals
Huntsville, AL 35811

REV. 01/10

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

Senna Lax S
(click image for full-size original)
SENNALAX-S
senna and docusate sodium tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0848(NDC:0603-0283)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
ALCOHOL
FD&C YELLOW NO. 6
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM BENZOATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0848-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 02/15/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-0848)

Revised: 03/2019 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.

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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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