PERDIEM- sennosides, stimulant laxative pill
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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

Sennosides, USP, 15 mg

Purpose

Stimulant Laxative

Uses

● relieves occasional constipation (irregularity)

● generally produces bowel movement in 6 to 12 hours

Warnings

Do not use laxative product when abdominal pain, nausea or vomiting are present

Ask a doctor or pharmacist before use if you

● have noticed a sudden change in bowel habits that persists over a period of 2 weeks

● are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

● do not use for a period longer than 1 week

Stop use and ask a doctor if

● rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may 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

● swallow pill(s) with a glass of water

● swallow pill(s) whole, do not crush, break or chew

Adults and children 12 years of age and older	2 pills once or twice daily
Children 6 to under 12 years of age	1 pill once or twice daily
Children under 6 years of age	ask a doctor

Other Information

● each pill contains: calcium 55mg

● sodium free

● protect from moisture

● store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients

Acacia, alginic acid, black iron oxide, carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dibasic calcium phosphate, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, shellac, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, yellow iron oxide

Questions?

call 1-800-452-0051

Package/Label Principal Display Panel

Primary Label

Primary Label

Primary Label

PERDIEM
sennosides, stimulant laxative pill

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-6025
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	15 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
ALGINIC ACID (UNII: 8C3Z4148WZ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-6025-60	1 in 1 CARTON; Type 0: Not a Combination Product	11/01/2007	10/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/01/2007	10/31/2018

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2019

Document Id: 805a35a0-c059-4b74-b950-2c33eb37b4a9

Set id: 7374ae02-74d4-4250-9116-21872e9545ed

Version: 4

Effective Time: 20190124

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC