SENNOSIDES- sennosides tablet, film coated 
REMEDYREPACK 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.

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1122- Cardinal

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

■ relieves occasional constipation (irregularity)

■ generally produces a bowel movement in 6-12 hours

Do not use

■ laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

■ stomach pain

■ nausea

■ 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 professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

■ take preferably at bedtime or as directed by a doctor

AgeStarting DosageMaximum Dosage

adults and children 12 years of age

and over

2 tablets once a day

4 tablet twice a day

children 6 to under 12 years

1 tablets once a day

2 tablets once 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

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc

Questions or comments?

Call 1-800-231-4670 Monday-Friday 9AM-5PM EST

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Sennosides

GENERIC: Sennosides

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-3387-0

NDC: 70518-3387-1

NDC: 70518-3387-2

NDC: 70518-3387-3

COLOR: brown

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: 1122;1122

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

MM2

MM3

MM4

SENNOSIDES 
sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3387(NDC:70000-0447)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
TALC (UNII: 7SEV7J4R1U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 1122;1122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3387-0100 in 1 BOX03/15/2022
1NDC:70518-3387-11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70518-3387-2100 in 1 BOX03/16/2022
2NDC:70518-3387-31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/15/2022
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2022
Document Id: da69d452-61fd-45cc-e053-2a95a90a36f2
Set id: 0da6311d-9b6f-408f-855a-8dc069fc4c4f
Version: 1
Effective Time: 20220317
 
REMEDYREPACK INC.