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Guaifenesin 1200 mg 1200 mg Tablet, Extended Release — NDC 43598-0108-37 package photo

Guaifenesin 1200 mg 1200 mg Tablet, Extended Release

by Dr. Reddy's Laboratories Inc. · 3 BLISTER PACK in 1 CARTON (43598-108-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 43598-0108-37
🏷️ FDA NDC (as labeled) 43598-108-37 billing pads the product segment with a zero
OTC Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 43598-108-37
Product NDC 43598-108
11-digit billing NDC 43598010837
RxCUI 310621, 636522
UNII 495W7451VQ
Application # ANDA215932
SPL Set ID 525fda90-134c-f038-c403-eb5ffc1fb1f1
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN
Why two NDCs? The FDA registers this code as 43598-108-37 — 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 → 43598-0108-37. 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

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA215932 (ANDA)
Labeler code43598
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio158 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

📖 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 Pink
ShapeOval
Imprint12
Size22 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 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 5Y0974F5PW
    Hydroxypropyl cellulose is a plant-derived thickener and binder made by chemically treating cellulose. In medicines, it helps hold tablets together, thickens liquids, and can form a protective coating on capsules.
  • UNII 39J80LT57T
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
  • UNII 0HO1H52958
    Hypromellose 2910 is a plant-derived cellulose that forms a protective coating around tablets or capsules. It slows how fast the medicine releases, helps protect the active ingredient, and improves how the product looks.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

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

The official label also statescarbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

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.

💲 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
Mucus Relief ER 1200 mg 00536-1249-71 Rugby 14 tablets $0.445 — Availability likely —
Rugby Mucus Relief ER 1200 mg 00536-1451-88 Rugby 7 tablets $0.445 — Availability likely —
good neighbor pharmacy mucus er 1200 mg 46122-0683-74 Amerisource 1 tablet $0.445 — Availability likely —
Good Neighbor Pharmacy Mucus ER 1200 mg 46122-0814-04 Amerisource 7 tablets $0.445 — Availability likely —
Leader Mucus Relief 1200 mg 70000-0721-01 Cardinal 7 tablets $0.445 — Availability likely —
Mucus Relief 1200 mg 70000-0730-01 LEADER/ 14 tablets $0.445 — Availability likely —
Mucus Relief 1200 mg 70677-1051-01 Strategic 1 tablet $0.445 — Availability likely —
Guaifenesin 1200 mg 70677-1258-01 Strategic 14 tablets $0.445 — Availability likely —
Mucus Relief 1200 mg 83324-0096-14 CHAIN 14 tablets $0.445 — Availability likely —
Mucus Relief Extended Release Maximum Strength 1200 mg 70000-0479-01 CARDINAL 14 tablets $0.469 — FDA listed —
Good Sense Mucus ER 1200 mg 00113-3650-00 L. 14 tablets — — FDA listed —
Good Sense Mucus ER 1200 mg 00113-4077-01 L. 7 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0033-01 WALGREEN 14 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0570-27 Walgreens 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 00363-0832-14 Walgreens 14 tablets — — FDA listed —
Mucus Relief 1200 mg 00536-1392-88 Rugby 1 tablet — — FDA listed —
Mucus Relief Extended Release 1200 mg 11673-0732-14 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11673-0840-27 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11822-4260-01 RITE 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 21130-0399-01 Better 14 tablets — — FDA listed —
Guaifenesin 1200 mg 21130-0554-27 Safeway, 14 tablets — — FDA listed —
Guaifenesin 1200 mg 25000-0041-12 MARKSANS 500 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 30142-0962-14 Kroger 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 36800-0932-14 TOP 14 tablets — — Discontinued —
Mucus Relief Extended Release Maximum Strength 1200 mg 37808-0762-14 H 14 tablets — — FDA listed —
Mucus Relief 1200 mg 37835-0412-28 Bi-Mart 28 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 41226-0724-89 KROGER 14 tablets — — FDA listed —
mucus relief 1200 mg 41250-0654-02 Meijer 14 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 41415-0997-14 PUBLIX 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 41520-0732-14 Care 14 tablets — — FDA listed —
mucus er 1200 mg 42507-0471-14 HyVee 7 tablets — — FDA listed —
Guaifenesin 1200 mg 43598-0009-25 Dr. 14 tablets — — FDA listed —
Guaifenesin 1200 mgthis 43598-0108-37 Dr. 14 tablets — — FDA listed —
Equate Mucus Relief 1200 mg 49035-0284-48 Wal-Mart 48 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 49483-0724-70 TIME 70 tablets — — FDA listed —
Mucinex Maximum Strength 1200 mg 50090-2301-00 A-S 7 tablets — — Discontinued —
mucus extended release 1200 mg 51316-0400-55 CVS 7 tablets — — FDA listed —
Mucus And Chest Congestion 1200 mg 51316-0520-74 CVS 7 tablets — — FDA listed —
Mucus Relief 1200 mg 51316-0724-94 CVS 14 tablets — — FDA listed —
mucus relief 1200 mg 51316-0728-74 CVS 7 tablets — — FDA listed —
Guaifenesin 1200 mg 51660-0567-54 Ohm 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53041-0191-48 Guardian 7 tablets — — FDA listed —
Guaifenesin Extended-Release 1200 mg 53041-0234-37 Guardian 7 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53942-0204-02 Demoulas 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 53943-0234-07 Discount 14 tablets — — FDA listed —
Mucus Relief 1200 mg 55319-0551-07 Family 1 tablet — — FDA listed —
Mucus Relief 1200 mg 55319-0733-14 Family 1 tablet — — FDA listed —
dg health mucus er max 1200 mg 55910-0626-74 Dolgencorp 14 tablets — — FDA listed —
DG health mucus er max 1200 mg 55910-0887-74 Dolgencorp 7 tablets — — FDA listed —
Crcle Guaifensin Extended Release Tablet, 1200 mg 57483-0280-02 Innovus 56 tablets — — FDA listed —
Giltuss EX Maximum Strength Expectorant 1200 mg 58552-0341-07 Gil 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0811-01 Aurohealth 14 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0865-03 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 59726-0237-07 P 1 tablet — — FDA listed —
Mucus Relief 1200 mg 61504-0204-02 AMERIFOODS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0569-93 Granules 2000 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0840-71 Granules 10 tablets — — FDA listed —
Mucinex Maximum Strength 1200 mg 63824-0023-02 Reckitt 1 tablet — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 63868-0148-14 CHAIN 7 tablets — — FDA listed —
Guaifenesin 1200 mg 65162-0037-03 Amneal 30 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 67091-0404-02 WINCO 7 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 68196-0033-56 SAM'S 14 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0405-14 SAM'S 56 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0960-56 Sam's 14 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 68196-0996-56 SAM'S 14 tablets — — FDA listed —
berkley and jensen mucus relief 1200 mg 68391-0000-45 BJWC 14 tablets — — FDA listed —
Mucus Relief 1200 mg 68391-0724-95 BJWC 84 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 69168-0460-32 Allegiant 100 tablets — — FDA listed —
Guaifenesin 1200 mg 69842-0335-16 CVS 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 69842-0732-14 CVS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 69848-0018-16 GRANULES 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71309-0461-56 Safrel 56 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 72036-0204-02 HARRIS 14 tablets — — FDA listed —
Mucus Relief 1200 mg 72090-0012-01 Pioneer 100 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0613-55 Amazon.com 7 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0650-02 Amazon.com 14 tablets — — FDA listed —
Curist Mucus Relief Maximum Strength 1200 mg 72559-0013-11 Little 14 tablets — — FDA listed —
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg 73581-0402-01 YYBA 100 tablets — — FDA listed —
Guaifenesin 1200 mg 76162-0031-56 TOPCO 14 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0409-01 Topco 7 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0523-01 Topco 14 tablets — — FDA listed —
Mucus Relief 1200 mg 79481-1204-01 Meijer 14 tablets — — FDA listed —
equate mucus relief 1200 mg 79903-0327-14 WALMART 7 tablets — — FDA listed —
Betr chest congestion relief 1200 mg 80267-0002-74 Live 14 tablets — — FDA listed —
Betr remedies chest congestion relief 1200 mg 80267-0010-74 Live 1 tablet — — FDA listed —
Guaifenesin 1200 mg 80513-0413-11 Advanced 110 tablets — — FDA listed —
Expectorant Guaifenesin Extended-Release 1200 mg 81179-0007-04 YET 70 tablets — — FDA listed —
Mucus Relief 1200 mg 81522-0204-02 FSA 14 tablets — — FDA listed —
Up And Up Mucus Relief 1200 mg 82442-0503-01 Target 7 tablets — — FDA listed —
Guaifenesin - Odaat 1200 Mg 83139-0175-01 LODAAT 100 tablets — — FDA listed —
Mucus Relief 1200 mg 84324-0034-01 NUVICARE 24 tablets — — FDA listed —
Dr Simi Mucus Relief Expectorant 1200 mg 85786-0301-14 Farmacias 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71179-0002-21 VESPYR 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0857-93 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 73581-0403-01 YYBA 100 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 70677-1320-01 Strategic 14 tablets — — 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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 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.

🔬 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 Guaifenesin 1200 mg (this brand).

Top reported reactions

Dyspnoea561
Pneumonia529
Nausea480
Fatigue450
Pain423
Diarrhoea402
Cough368

Age at onset

Neonate2
Infant2
Child20
Adolescent19
Adult530
Elderly535

Reporter sex

7,226 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization2,889
Life-threatening332
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 592 0
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
43598-0108-37 You're viewing this 3 BLISTER PACK in 1 CARTON (43598-108-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2022-09-01 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 43598-108-37, 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: 43598-0108-37, written without dashes as 43598010837. 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 43598-0108-37, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (37) 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 Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddy's Laboratories Inc. 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Use(s) helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 91 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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg) adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours (for 1200 mg) children under 12 years of age: do not use

⚠️ Warnings 102 words ▾

Warnings Applicable warning(s) in 201.66(c)(5)(i) and (ii) Do not use For children under 12 years age Ask a doctor before use if 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 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 Pregnancy/Breastfeeding, ask a health professional before use.

Keep out of reach of children In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 13 words ▾

Active ingredient(s) Guaifenesin 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 mg)

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

🎯 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 ↗
← 43598-0106-58 · Dr. 43598-0109-27 · Dr. →
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.