True Laxative

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:46:45

Label at a glance#

ProductTrue Laxative
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure8 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Dosage and administration

do not take more than directed unless advised by your doctor the bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim adults and children 17 years of age and older: use once a day fill to the top of the bottle cap which will provide the correct dose (17g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with star...

Storage and handling

store at 20° - 25°C (68° - 77°F) tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Label contents#

Full prescribing information#

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 grams (cap filled to line)

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

Warnings

WARNINGS SECTION

Allergy alert:Do not use if you are allergic to polyethylene glycol

Do not useif you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

Ask a doctor or pharmacist before use if you are

taking a prescription drug

When using this productyou may have loose, watery, more frequent stools

Stop use and ask a doctor if

  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
  • you get diarrhea
  • you need to use a laxative for longer than 1 week
    If pregnant or breast feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed unless advised by your doctor
  • the bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim
  • adults and children 17 years of age and older:
  • use once a day
  • fill to the top of the bottle cap which will provide the correct dose (17g)
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • do not combine with starch-based thickeners used for difficulty swallowing
  • ensure that the powder is fully dissolved before drinking
  • do not drink if there are any clumps
  • do not use more than 7 days
  • children 16 years of age or under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-1064-2GM - Gram83035-10643cb550d2-5b81-415b-923e-a8b98a387c8312024-08-12
83035-1064-3GM - Gram83035-106430591a88-e506-49a6-9ffc-fdf93c56e4c312025-02-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-106483035-1064-2, 83035-1064-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46b6ed60-c04e-f349-e063-6294a90ad99084672cfc-d491-457d-a4df-0d7b1619aa7b2025-12-24WarningsExact identifier
spl id: 46b6ed60-c04e-f349-e063-6294a90ad990
spl set id: 84672cfc-d491-457d-a4df-0d7b1619aa7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.