True Laxative by Singular Dreamer, Ltd dba True Marker

True Laxative by

Drug Labeling and Warnings

True Laxative by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRUE LAXATIVE- polyethylene glycol 3350 powder 
Singular Dreamer, Ltd dba True Marker

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Active ingredient (in each dose)

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

Purpose

Osmotic Laxative

Uses

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

Warnings

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.

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

Directions

  • 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

  • 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

none

Questions or comments?

1-800-645-2158

image description

TRUE LAXATIVE 
polyethylene glycol 3350 powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83035-1064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83035-1064-2238 g in 1 BOTTLE; Type 0: Not a Combination Product07/10/2024
2NDC: 83035-1064-3476 g in 1 BOTTLE; Type 0: Not a Combination Product01/13/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081207/10/202412/31/2025
Labeler - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 12/2025
Document Id: 46b6ed60-c04e-f349-e063-6294a90ad990
Set id: 84672cfc-d491-457d-a4df-0d7b1619aa7b
Version: 3
Effective Time: 20251224