OTC Medication Information: 2 IN 1LAXATIVE STOOL SOFTENER AND STIULANT LAXATIVE

2 IN 1LAXATIVE STOOL SOFTENER AND STIULANT LAXATIVE- docusate sodium and sennosides tablet, coated
RITE AID

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 ingredients (each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool softener

Stimulant laxative

Uses

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

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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take upto 1 tablet daily
children under 2 years ask a doctor

Other information

each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-290-4008

209R-Riteaid-Laxative-carton-label-100s
(click image for full-size original)

2 IN 1LAXATIVE STOOL SOFTENER AND STIULANT LAXATIVE
stool softener-stimulant laxative tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-8005
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
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE
CARNAUBA WAX
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C RED NO. 40
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color red Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL097
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-8005-5 100 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 06/01/2020
Labeler — RITE AID (014578892)
Registrant — TIME CAP LABORATORIES, INC. (037052099)
Establishment
Name Address ID/FEI Operations
TIME CAP LABORATORIES, INC. 037052099 manufacture (11822-8005)

Revised: 01/2022 RITE AID

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.

Terms of Use | Copyright © 2022. All Rights Reserved.