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GAVILAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution, 510 g — NDC 43386-0312-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GAVILAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution, 510 g — NDC 43386-312-14 (Billing 43386-0312-14)

by Lupin Pharmaceuticals,Inc. · 510 g in 1 BOTTLE

This is a package of 510 g of GAVILAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution from Lupin Pharmaceuticals,Inc., marketed since Oct 2009 and currently FDA-listed; retail pharmacies pay about $0.0204 per g (NADAC). It is the main listing for this product, which comes in 4 package sizes.

NDC 43386-0312-14
🏷️ FDA NDC (as labeled) 43386-312-14 billing pads the product segment with a zero
This package
Contains510 g Cost per g$0.0204 NADAC Per package$10.40 / 510 g Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.0304/unit — full pricing hub ↓
Main listing for product 43386-312 · Also comes in: 119 g 43386-312-07 238 g 43386-312-08 850 g 43386-312-85
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 43386-312-14 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43386 labeler · 312 product · 14 package
Package marketed since
Oct 9, 2009
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Billing quantity
510 g per package
Barcode (UPC)
0343386312085
Medicaid fills, this package
162,817 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43386-312-14
Product NDC 43386-312
11-digit billing NDC 43386031214
NCPDP billing unit GM — per gram (weight)
RxCUI 876193, 876214
UNII G2M7P15E5P
UPC 0343386312085
Application # ANDA091077
SPL Set ID 19672e23-1606-497e-a112-939af33af195
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-10-09
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance POLYETHYLENE GLYCOL 3350

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46600033002910
GPI class GaviLAX
GCN Seq No 041843
GCN 86212
HICL code 022819
Ingredient (HICL) Polyethylene Glycol 3350
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name GAVILAX POWDER
FDB brand name Gavilax
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 041843
  • GCN: 86212
  • GPI-14 (Medi-Span): 46600033002910
  • HICL (First Databank): 022819
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 876193
Why two NDCs? The FDA registers this code as 43386-312-14 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0312-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Osmotic Laxative class.

Pharmacologic class Osmotic Laxative
How it works Osmotic Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GAVILAX POWDER Ingredient Polyethylene Glycol 3350
📗 Our plain-language guide HelloPharmacist
  • You can generally expect a bowel movement within 1 to 3 days after taking it. It's not meant to work in an hour like some other laxatives — it works gradually. If you haven't gone...
  • How long does it take for Polyethylene Glycol 3350 to work?
  • You can stir it into any 4 to 8 ounces of beverage — water, juice, coffee, tea, whatever you like, cold or hot. The key is to stir it well until it's completely dissolved. Don't dr...
  • Can I mix it into any drink, or does it have to be water?
📖 Read our full Polyethylene Glycol 3350 guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.020 $10.40 / 510 g
Medicaid paysCMS SDUD · 12 mo $0.0304 $15.50 / 510 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.024 $0.019
▲ Up 4% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
43386-0312-07 43386-312-07 119 g in 1 BOTTLE — — 2009-10-09 — Active
43386-0312-08 43386-312-08 238 g in 1 BOTTLE Sample $0.0241 / g $5.74 2009-10-09 — Active
43386-0312-14 You're viewing this Main listing 510 g in 1 BOTTLE Sample $0.0204 / g $10.39 2009-10-09 — Active
43386-0312-85 43386-312-85 850 g in 1 BOTTLE — — 2009-10-09 — Active

You're viewing one of 4 pack sizes for this product.

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0204 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 75% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 510 g — 510 g in 1 bottle.
How does this package differ from NDC 43386-0312-07?
Both are GAVILAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution — the drug itself is identical. This page's package is the 510 g one, while NDC 43386-0312-07 is the 119 g package.
What NDC number is used to bill for this package of GAVILAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Polyethylene Glycol 3350 3350 17 g/17g 51672-2104-03 Sun 765 g $0.014 — Availability likely save 30%
Gavilax 3350 17 g/17gthis 43386-0312-14 Lupin 510 g $0.020 — Availability likely —
rugby PEG 3350 3350 17 g/17g 00536-1052-24 Rugby 238 g $0.024 — Availability likely +18%
good neighbor pharmacy clearlax 3350 17 g/17g 46122-0805-29 Amerisource 238 g $0.024 — Availability likely +18%
Polyethylene Glycol 3350 17 g/17g 68001-0505-55 BluePoint 238 g $0.024 — Availability likely +18%
Polyethylene Glycol 3350 3350 17 g/17g 68001-0607-55 BluePoint 238 g $0.024 — Availability likely +18%
Leader ClearLax 3350 17 g/17g 70000-0704-01 Cardinal 238 g $0.024 — Availability likely +18%
Polyethylene Glycol 3350 3350 17 g/17g 83324-0002-08 CHAIN 238 g $0.024 — Availability likely +18%
Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d 45861-0083-05 Pharmaceutica 238 ds $0.024 — Availability likely +20%
Clearlax 3350 17 g/17g 70677-1068-01 STRATEGIC 238 g $0.024 — Availability likely +20%
Good Sense Clear Lax 3350 17 g/17g 00113-0306-01 L. 119 g $0.029 — Availability likely +40%
Polyethylene Glycol 3350 3350 17 g/17g 45802-0868-01 Padagis 119 g $0.029 — Availability likely +40%
Good Neighbor Pharmacy ClearLax 3350 17 g/17g 46122-0014-31 Amerisource 119 g $0.029 — Availability likely +40%
leader clearlax 3350 17 g/17g 70000-0415-01 Cardinal 119 g $0.029 — Availability likely +40%
foster and thrive clearlax 3350 17 g/17g 70677-1109-01 Strategic 119 g $0.029 — Availability likely +40%
Polyethylene Glycol 3350 3350 17 g/17g 63739-0760-02 SKY 14 packets $1.127 — Discontinued +5434%
Polyethylene glycol 3350 3350 17 g/17g 00904-6931-26 Major 14 packets $1.224 — Availability likely +5911%
Polyethylene Glycol (3350) 3500 17 g/17g 51079-0306-30 Mylan 30 pouches $1.224 — Availability likely +5911%
Polyethylene Glycol 3350 3350 17 g/17g 62559-0157-10 ANI 100 packets $1.224 — Availability likely +5911%
Polyethylene Glycol 3350 3350 17 g/17g 72603-0302-02 NorthStar 14 packets $1.224 — Availability likely +5911%
Polyethylene Glycol 3350 3350 17 g/17g 81033-0762-01 Kesin 100 packets $1.224 — Availability likely +5911%
Polyethylene Glycol 3350 3350 17 g/17g 60687-0431-92 American 100 pouches $1.224 — Availability likely +5911%
good sense clearlax 3350 17 g/17g 00113-1023-03 L. 510 g — — FDA listed —
injoy constipation relief 3350 17 g/17g 00113-6900-02 L. 1 bottle — — FDA listed —
smooth lax 3350 17 g/17g 00363-0306-00 Walgreen 17 g — — FDA listed —
smoothlax 3350 17 g/17g 00363-1323-03 Walgreen 510 g — — FDA listed —
Walgreens 3350 17 g/17g 00363-5260-07 WALGREEN 119 g — — FDA listed —
MiraLAX Orange Flavor 3350 17 g/17g 11523-0122-01 Bayer 238 g — — FDA listed —
MiraLAX 3350 17 g/17g 11523-4357-02 Bayer 20 packets — — FDA listed —
MiraLAX 3350 17 g/17g 11523-7234-01 Bayer 17 g — — Discontinued —
MiraLAX 3350 17 g/17g 11523-7268-03 Bayer 10 packets — — FDA listed —
MiraLAX 3350 17 g/17g 11523-7341-01 Bayer 612 g — — Discontinued —
Polyethylene Glycol 3350 Nf 3350 17 g/17g 11534-0180-19 SUNRISE 119 g — — FDA listed —
up and up powderlax 3350 17 g/17g 11673-0306-01 Target 119 g — — FDA listed —
Laxative 3350 17 g/17g 11822-0306-03 Rite 119 g — — FDA listed —
laxative 3350 17 g/17g 11822-1199-00 Rite 238 g — — FDA listed —
Gavilax 3350 17 g/17g 17856-0310-01 Atlantic 50 cups — — FDA listed —
Gavilax 3350 17 g/17g 17856-0312-01 ATLANTIC 17 g — — FDA listed —
Clearlax 3350 17 g/17g 21130-0637-02 Safeway 238 g — — FDA listed —
signature care clearlax 3350 17 g/17g 21130-0847-01 Safeway 119 g — — FDA listed —
gentle lax 3350 17 g/17g 30142-0306-01 Kroger 119 g — — FDA listed —
Gentlelax 3350 17 g/17g 30142-0504-02 Kroger 238 g — — FDA listed —
Kroger 3350 17 g/17g 30142-0526-07 KROGER 119 g — — FDA listed —
Topcare ClearLax 3350 17 g/17g 36800-0306-01 Topco 119 g — — FDA listed —
clear lax 3350 17 g/17g 37808-0306-01 H 119 g — — FDA listed —
equaline clearlax 3350 17 g/17g 41163-0306-01 United 119 g — — FDA listed —
Dulcolax 3350 17 g/17g 41167-0223-00 Chattem, 765 g — — FDA listed —
clear lax 3350 17 g/17g 41250-0306-01 Meijer 119 g — — FDA listed —
care one clearlax 3350 17 g/17g 41520-0306-01 American 119 g — — FDA listed —
clear lax 3350 17 g/17g 42507-0306-01 HyVee 119 g — — FDA listed —
365 WHOLE FOODS MARKET Polyethylene Glycol 3350 3350 17 g/17g 42681-0059-01 Whole 119 g — — FDA listed —
equate clear lax 3350 17 g/17g 49035-0306-01 Wal-Mart 119 g — — FDA listed —
Mix-In Laxative Packets 3350 17 g/17g 49035-0906-03 Wal-Mart 10 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 50090-2430-00 A-S 238 g — — FDA listed —
Gavilax 3350 17 g/17g 50090-5310-00 A-S 238 g — — FDA listed —
Discount Drug Mart 3350 17 g/17g 53943-0652-14 DISCOUNT 238 g — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-2328-05 Cardinal 7 packets — — FDA listed —
MiraLAX 3350 17 g/17g 55154-5035-06 Cardinal 6 packets — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-8090-05 Cardinal 5 pouches — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-8091-05 Cardinal 5 pouches — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 55154-8184-05 Cardinal 7 pouches — — FDA listed —
Exchange Select ClearLax 3350 17 g/17g 55301-0306-03 Army 510 g — — FDA listed —
Comfortlax 3350 17 g/17g 55319-0056-24 Family 119 g — — FDA listed —
dg health clearlax 3350 17 g/17g 55910-0306-01 Dolgencorp, 119 g — — FDA listed —
dg health clearlax 3350 17 g/17g 55910-0846-02 Dolgencorp 238 g — — FDA listed —
clearlax 3350 17 g/17g 56062-0306-02 Publix 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 57896-0489-14 Geri-Care 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 57896-0490-03 Gericare 30 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 58602-0805-01 Aurohealth 119 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 59556-0762-01 Strides 10 packets — — Discontinued —
clearlax 3350 17 g/17g 59640-0797-02 H 238 g — — FDA listed —
purelax 3350 17 g/17g 59779-0306-01 CVS 119 g — — FDA listed —
Gavilax 3350 17 g/17g 63187-0368-23 Proficient 238 g — — FDA listed —
EasyLAX 3350 17 g/17g 63941-0489-14 VALU 238 g — — FDA listed —
kirkland signature laxaclear original prescription strength 3350 17 g/17g 63981-0306-04 Costco 850 g — — FDA listed —
Welby ClearLax 3350 17 g/17g 64024-0306-02 Aldi, 238 g — — FDA listed —
Winco 3350 17 g/17g 67091-0447-08 WINCO 238 g — — FDA listed —
Members Mark clearlax 3350 17 g/17g 68196-0306-07 Sam's 3 bottles — — FDA listed —
berkley and jensen clearlax 3350 17 g/17g 68391-0306-02 BJWC 765 g — — FDA listed —
Gavilax 3350 17 g/17g 68788-7508-02 Preferred 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 68788-8601-02 Preferred 238 g — — FDA listed —
Good Sense Clear Lax 3350 17 g/17g 68788-8795-02 Preferred 238 g — — FDA listed —
Polyethylene Gycol 3350 3350 17 g/g 69168-0473-55 Allegiant 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 69230-0324-32 Camber 7 packets — — FDA listed —
purelax 3350 17 g/17g 69842-0458-01 CVS 119 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 70000-0699-02 CARDINAL 10 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72090-0036-01 PIONEER 30 packets — — FDA listed —
rugby PEG 3350 3350 17 g/17g 72162-2155-02 Bryant 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72162-2172-02 Bryant 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72162-2180-02 Bryant 238 g — — FDA listed —
basic care clearlax 3350 17 g/17g 72288-0020-02 Amazon.com 238 g — — FDA listed —
basic care clearlax 3350 17 g/17g 72288-0499-02 Amazon.com 238 g — — FDA listed —
careone clearlax 3350 17 g/17g 72476-0723-03 Retail 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72657-0196-16 GLENMARK 765 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g 73581-0913-40 YYBA 40 packets — — FDA listed —
Topcare ClearLax 3350 17 g/17g 76162-0119-02 Topco 238 g — — FDA listed —
MiraLAX 3350 17 g/17g 76420-0489-10 ASCLEMED 10 packets — — FDA listed —
ez2go Polyethylene Glycol 3350 3350 17 g/17g 76470-0050-50 Valley 119 g — — FDA listed —
Polyethylene Glycol 3350 Powder for Solution 3350 17 g/17g 76470-0069-69 VALLEY 238 g — — FDA listed —
clearlax 3350 17 g/17g 79481-0090-03 Meijer, 510 g — — FDA listed —
Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d 79739-7116-01 LGM 7 ds — — FDA listed —
Equate ClearLAX 3350 17 g/17g 79903-0114-14 WALMART 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 84386-0125-08 Aurobindo 119 g — — FDA listed —
Good Sense Clear Lax 3350 17 g/17g 71205-0447-38 Proficient 238 g — — FDA listed —
Clearlax 3350 17 g/17g 72288-0033-03 Amazon.com 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 87362-0119-01 The 119 g — — FDA listed —
Peg3350 3350 17 g/17g 00904-7534-26 Major 15 packets — — FDA listed —
Clearlax 3350 17 g/17g 72288-0471-09 Amazon.com 765 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 50844-0772-01 L.N.K. 30 packets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Polyethylene Glycol 3350 inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesnone

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA091077 (ANDA)
Labeler code43386
First marketedOct 2009
Product typeHuman Otc Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 153 words ▾

Directions do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line. adults and children 17 years of age and older: use once a day fill to top of line in cap which is marked to indicate the correct dose (17 g) 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 printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

⏱️ Dosage and Administration 53 words ▾

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.

⚠️ Warnings 30 words ▾

WARNINGS 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

🧪 Active Ingredient 12 words ▾

Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)……………………Osmotic Laxative

🧪 Inactive Ingredients 3 words ▾

Inactive Ingredient none

🎯 Purpose 16 words ▾

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

📄 Ask a Doctor Before Use If 53 words ▾

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

📄 Keep Out of Reach of Children 23 words ▾

Keep out of the reach of children In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

📄 Questions or Comments 10 words ▾

Questions or comments? 1-866-403-7592 Dissolves in any beverages Sugar Free

📄 Package Label / Principal Display Panel 115 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 43386-312-08 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT

8.3OZ (238 g) NDC 43386-312-85 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 50 ONCE-DAILY DOSES NET WT

29.9OZ (850 g) NDC 43386-312-07 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 7 ONCE-DAILY DOSES NET WT

4.1OZ (119 g) NDC 43386-312-14 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 30 ONCE-DAILY DOSES NET WT

17.9OZ (510 g) 238g Drug facts- back 238 g 850 g 4.1 oz 119 g back 17.9 oz

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
162.8K
Units reimbursed last 4 qtrs
91.2M
Gross reimbursed last 4 qtrs
$2.78M
Avg / prescription
$17.05
Avg / unit
$0.0304
Latest quarter Q1 2026
37.2KRx
Medicaid pays / g
$0.0304
gross reimbursed
vs
NADAC / g
$0.0204
acquisition cost
=
Spread
+$0.0100
+49% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 69,104 Rx Managed care · 93,713 Rx
State Medicaid map
Alaska: no data reported AK Maine: 498,780 units · 35,755 per 100k residents ME Washington: no data reported WA Idaho: 68,340 units · 3,480 per 100k residents ID Montana: no data reported MT North Dakota: 157,080 units · 20,061 per 100k residents ND Minnesota: 5,815,734 units · 101,372 per 100k residents MN Wisconsin: 145,078 units · 2,455 per 100k residents WI Michigan: 702,856 units · 7,003 per 100k residents MI New York: 18,154,302 units · 92,761 per 100k residents NY Vermont: 391,000 units · 60,433 per 100k residents VT New Hampshire: 715,020 units · 51,000 per 100k residents NH Oregon: 195,602 units · 4,621 per 100k residents OR Nevada: 159,626 units · 4,998 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 231,404 units · 7,216 per 100k residents IA Illinois: 236,130 units · 1,882 per 100k residents IL Indiana: 206,040 units · 3,003 per 100k residents IN Ohio: 1,760,010 units · 14,934 per 100k residents OH Pennsylvania: 2,404,974 units · 18,555 per 100k residents PA New Jersey: 914,485 units · 9,844 per 100k residents NJ Massachusetts: 22,429,715 units · 320,379 per 100k residents MA California: 1,319,027 units · 3,385 per 100k residents CA Utah: 31,586 units · 924 per 100k residents UT Colorado: 63,478 units · 1,080 per 100k residents CO Nebraska: 299,455 units · 15,139 per 100k residents NE Missouri: 1,348,950 units · 21,771 per 100k residents MO Kentucky: no data reported KY West Virginia: 301,410 units · 17,029 per 100k residents WV Virginia: 6,863,338 units · 78,744 per 100k residents VA Maryland: 2,143,173 units · 34,679 per 100k residents MD Connecticut: 1,730,872 units · 47,854 per 100k residents CT Rhode Island: 3,859,408 units · 352,457 per 100k residents RI Arizona: 139,740 units · 1,881 per 100k residents AZ New Mexico: 40,800 units · 1,930 per 100k residents NM Kansas: 49,980 units · 1,700 per 100k residents KS Arkansas: 233,136 units · 7,601 per 100k residents AR Tennessee: 1,538,398 units · 21,589 per 100k residents TN North Carolina: 5,796,960 units · 53,502 per 100k residents NC South Carolina: 4,951,318 units · 92,152 per 100k residents SC Delaware: 161,602 units · 15,674 per 100k residents DE Oklahoma: 38,777 units · 957 per 100k residents OK Louisiana: 190,770 units · 4,171 per 100k residents LA Mississippi: 79,467 units · 2,703 per 100k residents MS Alabama: no data reported AL Georgia: 3,684,920 units · 33,411 per 100k residents GA D.C.: 589,101 units · 86,760 per 100k residents DC Hawaii: no data reported HI Texas: 517,310 units · 1,696 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
924352,457
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 352,457 /100k
2 Massachusetts 320,379 /100k
3 Minnesota 101,372 /100k
4 New York 92,761 /100k
5 South Carolina 92,152 /100k
6 D.C. 86,760 /100k
7 Virginia 78,744 /100k
8 Vermont 60,433 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
510 g this page43386-0312-14 162,817 Rx · $2,775,487
238 g43386-0312-08 54,122 Rx · $603,163
119 g43386-0312-07 No Medicaid data
850 g43386-0312-85 No Medicaid data
Drug total (last 4 qtrs): 216,939 Rx · 105,288,282 units · $3,378,650 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.