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Mucinex Guaifenesin 600 mg Tablet, Extended Release, 20-count — NDC 50090-1340-00 package photo

Mucinex Guaifenesin 600 mg Tablet, Extended Release, 20-count

by A-S Medication Solutions · 1 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 50090-1340-00
🏷️ FDA NDC (as labeled) 50090-1340-0 billing pads the package segment with a zero
OTC Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 50090-1340-0
Product NDC 50090-1340
11-digit billing NDC 50090134000
NCPDP billing unit EA — each (per item)
RxCUI 636522, 891301
UNII 495W7451VQ
Application # NDA021282
SPL Set ID 92a70574-c373-4261-b20d-8ea8ef677bcf
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-07-03
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN
GPI-14 43200010007420
GPI class Mucinex
GCN Seq No 071885
GCN 35905
HICL code 000271
Ingredient (HICL) Guaifenesin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3J
Therapeutic class — specific (HIC3) Expectorants
AHFS code 48:16.00.00
AHFS class Expectorants
FDB label name MUCINEX ER 600 MG TABLET
FDB brand name Mucinex
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 50090-1340-0 — a 5-4-1 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 package segment → 50090-1340-00. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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.

🏭 Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderRECKITT BENCKISER LLC
FDA applicationNDA021282 (NDA)
Labeler code50090
First marketedJul 2012
Product typeHuman Otc Drug
Portfolio2,774 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.

🩺 Clinical

Label name MUCINEX ER 600 MG TABLET Ingredient Guaifenesin
📖 What it is MedlinePlus · NLM

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin is what's called an expectorant — it works to thin and loosen the mucus sitting in your chest and airways. That makes it easier to cough the mucus up and out, so instea...
  • What exactly does guaifenesin do for my cough?
  • Guaifenesin is meant for short-term use. If your cough isn't getting better after 7 days, keeps coming back, or shows up alongside a fever, rash, or a headache that won't go away,...
  • How long can I take it before I should call my doctor?
📖 Read our full Guaifenesin 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.

💊 What it looks like

Color white
ShapeOval
ImprintMucinex;600
Size16 mm
ScoringNot scored
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.

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

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescarbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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 DailyMedingredient 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense mucus er 600 mg 00113-2023-60 L. 20 tablets $0.285 Availability likely
Mucus Relief Extended Release 600 mg 00536-1163-61 Rugby 100 tablets $0.285 Availability likely
Mucus Relief ER 600 mg 00904-6718-39 Major 100 tablets $0.285 Availability likely
Mucus Relief 600 mg 00904-6986-40 Major 500 tablets $0.285 Availability likely
Guaifenesin 600 mg 46122-0750-51 AMERISOURCE 10 tablets $0.285 Availability likely
Guaifenesin 600 mg 51660-0566-21 Ohm 20 tablets $0.285 Availability likely
Mucus Relief 600 mg 63739-0067-02 McKesson 10 tablets $0.285 Availability likely
Guaifenesin Extended-Release 600 mg 68094-0048-61 Precision 10 tablets $0.285 Availability likely
Leader Mucus Relief 600 mg 70000-0758-01 Cardinal 20 tablets $0.285 Availability likely
Guaifenesin 600 mg 70010-0199-05 GRANULES 500 tablets $0.285 Availability likely
Foster and Thrive Mucus Relief 600 mg 70677-1013-01 Strategic 10 tablets $0.285 Availability likely
Mucus Relief 600 mg 70677-1052-01 Strategic 1 tablet $0.285 Availability likely
Guaifenesin 600 mg 70677-1257-01 Strategic 20 tablets $0.285 Availability likely
foster and thrive mucus relief 600 mg 70677-1291-01 Strategic 20 tablets $0.285 Availability likely
Mucus Relief 600 mg 83324-0097-20 CHAIN 20 tablets $0.285 Availability likely
Guaifenesin 600 mg 68001-0561-17 BluePoint 10 tablets $0.325 FDA listed
Mucinex 600 mg 63824-0008-15 Reckitt 20 tablets $0.543 FDA listed
Mucinex 600 mg 68084-0572-01 American 1 tablet $0.543 FDA listed
Guaifenesin 600 mg 00363-0028-96 WALGREEN 20 tablets FDA listed
Mucus Relief Extended Release 600 mg 00363-0931-10 Walgreens 100 tablets Discontinued
Guaifenesin 600 mg 00363-9569-02 Walgreens 20 tablets FDA listed
Rugby Mucus Relief Er 600 mg 00536-1489-20 Rugby 20 tablets FDA listed
Mucus Relief 600 mg 00615-8637-39 NCS 30 tablets FDA listed
up and up mucus relief 600 mg 11673-0421-60 Target 20 tablets Discontinued
Guaifenesin 600 mg 11673-0539-02 TARGET 20 tablets FDA listed
Mucus Relief Extended-Release 600 mg 11673-0731-20 TARGET 20 tablets Discontinued
mucus relief 600 mg 11822-2123-01 Rite 20 tablets FDA listed
Mucus Relief 600 mg 11822-3252-07 Rite 40 tablets FDA listed
Mucinex 600 mg 17856-0008-02 ATLANTIC 1 tablet FDA listed
Guaifenesin 600 mg 21130-0179-67 Better 20 tablets FDA listed
Guaifenesin 600 mg 25000-0042-01 MARKSANS 20 tablets FDA listed
Guaifenesin 600 mg 30142-0961-20 Kroger 20 tablets FDA listed
Mucus Relief 600 mg 36800-0137-20 TOP 20 tablets Discontinued
Topco Mucus Relief 600 mg 36800-0226-16 Topco 100 tablets FDA listed
Mucus Relief 600 mg 37808-0830-20 H 20 tablets FDA listed
Mucus Relief 600 mg 37808-0935-40 H 40 tablets FDA listed
Mucus Relief 600 mg 37835-0408-40 Bi-Mart 40 tablets FDA listed
Mucus Relief 600 mg 41163-0731-20 United 20 tablets FDA listed
Mucus Relief 600 mg 41226-0723-02 KROGER 20 tablets FDA listed
mucus relief 600 mg 41250-0684-02 Meijer 20 tablets FDA listed
Guaifenesin 600 mg 41415-0996-20 Publix 20 tablets FDA listed
Mucus Relief Extended Release 600 mg 41520-0731-20 Care 20 tablets FDA listed
mucus er 600 mg 42507-0202-60 HyVee 20 tablets FDA listed
Mucus Relief 600 mg 42507-0253-03 HYVEE 20 tablets FDA listed
365 Whole Foods Market Guaifenesin 600 mg 42681-0057-01 Whole 20 tablets FDA listed
Guaifenesin 600 mg 43598-0008-40 Dr. 20 tablets FDA listed
Guaifenesin 600 mg 43598-0110-01 Dr. 20 tablets FDA listed
Guaifenesin Extended Release 600 mg 49483-0723-50 TIME 500 tablets FDA listed
Mucinex 600 mg 50090-0818-00 A-S 20 tablets FDA listed
Mucinex 600 mgthis 50090-1340-00 A-S 20 tablets FDA listed
Mucinex 600 mg 50090-2380-00 A-S 28 tablets FDA listed
Mucinex 600 mg 50090-6078-00 A-S 480 tablets FDA listed
Guaifenesin 600 mg 51316-0008-01 CVS 20 tablets FDA listed
Guaifenesin 600 mg 51316-0071-68 CVS 68 tablets FDA listed
Mucus And Chest Congestion 600 mg 51316-0299-01 CVS 20 tablets FDA listed
Mucus Relief 600 mg 51316-0470-01 CVS 20 tablets FDA listed
Mucus Relief 600 mg 53041-0190-16 Guardian 100 tablets FDA listed
Guaifenesin Extended-Release 600 mg 53041-0233-30 Guardian 10 tablets FDA listed
Mucus Relief 600 mg 53942-0203-02 Demoulas 20 tablets FDA listed
Mucus Relief 600 mg 53943-0233-32 Discount 10 tablets FDA listed
Mucus Relief ER 600 mg 55154-4153-00 Cardinal 10 tablets FDA listed
Mucinex 600 mg 55154-4680-00 Cardinal 1 tablet FDA listed
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg 55681-0301-01 TWIN 100 tablets FDA listed
Mucus Relief 600 mg 55910-0739-20 Dolgencorp, 20 tablets FDA listed
DG Health Mucus ER 600 mg 55910-0904-01 Dolgencorp, 20 tablets FDA listed
Mucus Relief 600 mg 57344-0203-02 AAA 10 tablets FDA listed
Crcle Guaifenesin Extended-Release Tablets, 600 mg 57483-0270-01 Innovus 100 tablets FDA listed
Giltuss EX Expectorant 600 mg 58552-0338-07 Gil 7 tablets FDA listed
Giltuss Diabetic Ex 600 mg 58552-0339-07 Gil 7 tablets FDA listed
Giltuss HBP EX Expectorant 600 mg 58552-0340-07 Gil 7 tablets FDA listed
Guaifenesin 600 mg 58602-0810-12 Aurohealth 40 tablets FDA listed
Guaifenesin 600 mg 58602-0853-12 Aurohealth 40 tablets FDA listed
Guaifenesin 600 mg 58602-0864-98 Aurohealth 20 tablets FDA listed
Mucus Relief 600 mg 59726-0734-20 P 1 tablet FDA listed
Guaifenesin 600 mg 62207-0570-30 Granules 20000 tablets FDA listed
Guaifenesin 600 mg 62207-0839-72 Granules 10 tablets FDA listed
Mucinex 600 mg 63187-0954-20 Proficient 20 tablets FDA listed
Mucinex 600 mg 63629-7115-01 Bryant 30 tablets FDA listed
Mucinex 600 mg 63629-7886-01 Bryant 20 tablets FDA listed
12 Hour Mucus Relief 600 mg 63868-0149-20 CHAIN 10 tablets FDA listed
Mucus Relief 600 mg 63941-0731-20 Best 20 tablets FDA listed
Guaifenesin 600 mg 65162-0036-02 Amneal 10 tablets FDA listed
Mucus Relief 600 mg 67091-0370-20 WinCo 20 tablets FDA listed
Mucus Relief 600 mg 67091-0403-02 WINCO 10 tablets FDA listed
Mucus Relief Extended Release 600 mg 67296-1467-07 Redpharm 1 tablet FDA listed
good sense mucus er 600 mg 67296-2223-02 Redpharm 20 tablets FDA listed
Mucinex 600 mg 67544-0149-53 Aphena 60 tablets FDA listed
Mucus Relief 600 mg 69168-0459-02 Allegiant 150 tablets FDA listed
Mucus Relief 600 mg 69256-0731-20 Harris 1 tablet FDA listed
mucus 600 mg 69842-0806-01 CVS 20 tablets FDA listed
Guaifenesin 600 mg 69848-0017-02 GRANULES 20 tablets FDA listed
Mucus Relief 600 mg 71335-2642-01 Bryant 30 tablets FDA listed
Mucus Relief 600 mg 71610-0499-12 Aphena 12 tablets FDA listed
Mucus Relief 600 mg 72036-0203-02 HARRIS 20 tablets FDA listed
Mucus Relief 600 mg 72090-0011-01 Pioneer 200 tablets FDA listed
basic care mucus er 600 mg 72288-0298-02 Amazon.com 20 tablets FDA listed
Curist Mucus Relief 600 mg 72559-0017-22 Little 200 tablets FDA listed
Guaifenesin 600 mg 73581-0400-02 YYBA 200 tablets FDA listed
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg 73581-0401-02 YYBA 200 tablets FDA listed
Topcare mucus er 600 mg 76162-0123-58 Topco 40 tablets FDA listed
Guaifenesin 600 mg 79903-0124-20 Walmart 20 tablets FDA listed
Guaifenesin Extended Release 600 mg 79903-0271-40 Wal-Mart 20 tablets FDA listed
equate mucus-er 600 mg 79903-0292-12 WALMART 40 tablets FDA listed
Mucus Relief 600 mg 80513-0403-20 Advanced 200 tablets FDA listed
Mucus Relief 600 mg 81522-0203-02 FSA 20 tablets FDA listed
Guaifenesin 600 mg 82804-0265-20 Proficient 20 tablets FDA listed
Mucus Relief 600 mg 84324-0026-01 NUVICARE 40 tablets FDA listed
Dr. Simi Mucus Relief 600 mg 85786-0302-40 Farmacias 20 tablets FDA listed
Mucus Relief 600 mg 85828-0723-02 Grocery 20 tablets FDA listed
Guaifenesin 600 mg 87448-1701-02 Northwestern 1 tablet Discontinued
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2012
On the market since
Jul 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mucinex (this brand).

Top reported reactions

Dyspnoea2,179
Fatigue1,791
Nausea1,724
Pneumonia1,659
Diarrhoea1,615
Cough1,579
Headache1,477

Age at onset

Neonate2
Infant2
Child53
Adolescent47
Adult1,878
Elderly2,018

Reporter sex

27,438 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization7,642
Life-threatening636
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,071 879
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50090-1340-00 You're viewing this 1 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2014-11-28 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50090-1340-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50090-1340-00, written without dashes as 50090134000. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50090-1340-00, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (1340) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 22 words

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 60 words

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 102 words

Warnings Do not use for children under 12 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 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.

📦 How Supplied / Storage and Handling 19 words

HOW SUPPLIED Product: 50090-1340 NDC: 50090-1340-0 20 TABLET, EXTENDED RELEASE in a BLISTER PACK / 1 in a CARTON

📦 Storage and Handling 6 words

Other information store at 20-25°C (68-77°F)

🧪 Active Ingredient 10 words

Active ingredient (in each extended-release bi-layer tablet) Guaifenesin 600 mg

🧪 Inactive Ingredients 23 words

Inactive ingredients carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

🎯 Purpose 2 words

Purpose Expectorant

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