LAXATIVE

Manufacturer
FRED'S INC. | Geri-Care Pharmaceutical Corp
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:47:27

Label at a glance#

ProductLAXATIVE
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 top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line adults and children 17 years of age and older: fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink use ...

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 the indicated “17 GRAMS” line)

Purpose

OTC - PURPOSE SECTION

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 use if 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 product you 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 top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
  • adults and children 17 years of age and older:
    • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • use once a day
  • use no more than 7 days
  • children 16 years of age or younger: 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

For serious adverse events call:

OTC - QUESTIONS SECTION

1-888-710-0006

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's Pharmacy

NDC 55315-369-31

original prescription strength

Laxative

polyethylene glycol 3350
Softens stool
powder for solution/ osmotic laxative

relieves occasional constipation (irregularity)

compare to the active ingredient in miralax
30 once daily doses
net wt 17.9 oz (510 g)

489-30489-30

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
55315-36955315-369-31

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

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07f41ea6bd6efb…

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
9aa0023b-e65f-9b24-e053-2995a90a7a4d392e5d0f-b90a-56df-e054-00144ff88e882019-12-26WarningsExact identifier
spl id: 9aa0023b-e65f-9b24-e053-2995a90a7a4d
spl set id: 392e5d0f-b90a-56df-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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