FDA-filed SPL labeling · retrieved through openFDA

Guaifenesin / Pseudoephedrine

Guaifenesin/pseudoephedrine is a combination medicine that loosens chest congestion and relieves nasal and sinus congestion caused by the common cold, hay fever, and upper respiratory allergies.

Brand names Mucus Relief DMucus DMucinex Dequate mucus dPoly-Vent IR +11 more
Drug class ⓘ Expectorant
OTC Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 54 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 27, 2018
Clinical labels in scope ⓘ54
AvailabilityOTC
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ132
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Guaifenesin / Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Guaifenesin/pseudoephedrine is a useful combination for relieving chest congestion and nasal or sinus congestion from colds, hay fever, and upper respiratory allergies. Always swallow extended-release tablets whole and never exceed the dose on your product's label. Check with your doctor or pharmacist first if you take any prescription medications — especially MAOIs — or if you have heart disease, high blood pressure, diabetes, or thyroid disease.
How we write & review this content — our editorial policy →

📖 Guaifenesin / Pseudoephedrine: Patient Information Guide

A plain-language walkthrough of Guaifenesin / Pseudoephedrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Guaifenesin/pseudoephedrine combines a chest decongestant (expectorant) with a nasal decongestant to address congestion from multiple angles. Supported uses across products include:

  • Loosening phlegm and thinning bronchial secretions to make coughs more productive
  • Temporarily relieving nasal congestion due to the common cold
  • Temporarily relieving nasal congestion due to hay fever or other upper respiratory allergies
  • Temporarily restoring freer breathing through the nose
  • Promoting nasal and/or sinus drainage
  • Temporarily relieving sinus congestion and pressure
  • Poly-Vent IR tablet is also indicated for runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes due to the common cold, hay fever, or upper respiratory allergies
💊How it's taken▾

The right dose and how often you take it depends on which product and strength you have — always check your product's label. Extended-release tablets (such as Equate Mucus D, Foster And Thrive Mucus Relief D, Guaifenesin and Pseudoephedrine HCl, and Guaifenesin D) are taken by mouth roughly every 12 hours and can be taken with or without food. Regular (immediate-release) tablets like Mucus Relief D film-coated tablet are taken every 4 hours with a full glass of water; Poly-Vent IR is also taken every 4 hours.

  • Swallow extended-release tablets whole — never crush, chew, or break them
  • Take all forms with a full glass of water
  • Do not exceed the maximum number of doses listed on your specific product label in 24 hours
  • If you miss a dose, follow your product label or ask your pharmacist; do not double up
🤒Side effects — in detail▾

This medicine is generally well tolerated, but pseudoephedrine is a stimulant and can cause:

  • Nervousness or restlessness
  • Dizziness
  • Trouble sleeping

Stop use and contact a doctor right away if these symptoms are severe, if your congestion symptoms do not improve within 7 days or return, or if they come back alongside fever, rash, or a persistent headache — those could point to a more serious illness.

⚠️Warnings & precautions▾

The single most important warning: do not take this product if you currently use a prescription MAOI — or have taken one in the past 2 weeks. MAOIs are used for depression, certain psychiatric or emotional conditions, and Parkinson's disease. Combining pseudoephedrine with an MAOI can cause a serious, potentially dangerous reaction. If you're not certain whether one of your prescription medicines is an MAOI, ask your pharmacist before taking this product.

  • Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, or diabetes — pseudoephedrine can affect all of these
  • Ask a doctor if you have trouble urinating due to an enlarged prostate gland
  • Ask a doctor if you have a persistent cough from smoking, asthma, chronic bronchitis, or emphysema, or a cough producing a large amount of mucus
  • Stop use and ask a doctor if you become nervous, dizzy, or sleepless
  • Stop use and ask a doctor if symptoms persist beyond 7 days, return, or occur with fever, rash, or a persistent headache
  • Keep out of reach of children; in case of overdose, contact Poison Control immediately at 1-800-222-1222
🔀What it interacts with▾

The main drug interaction to know about involves MAOIs. Always tell your doctor or pharmacist about all medications you take.

  • Prescription MAOIs (used for depression, psychiatric conditions, or Parkinson's disease) — do not use this product at the same time or within 2 weeks of stopping an MAOI; the combination can cause a serious reaction

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use if you currently take a prescription MAOI or have taken one in the past 2 weeks
  • Check with a doctor first if you have heart disease
  • Check with a doctor first if you have high blood pressure
  • Check with a doctor first if you have thyroid disease
  • Check with a doctor first if you have diabetes
  • Check with a doctor first if you have trouble urinating due to an enlarged prostate gland
  • Check with a doctor first if you have a chronic cough from smoking, asthma, chronic bronchitis, or emphysema
  • Check with a doctor first if your cough produces a large amount of mucus
  • If you are pregnant or breastfeeding, ask a health professional before use
  • Most extended-release products: not for children under 12; Poly-Vent IR may be used in children 6 and older as directed, and children 2–5 should consult a doctor first
🚑If you take too much▾

If you or someone else takes too much, get medical help or contact Poison Control right away at 1-800-222-1222. Act immediately — do not wait for symptoms to appear.

📦How to store it▾

store between 20-25°C (68-77°F)

📄 Written from Guaifenesin / Pseudoephedrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Guaifenesin / Pseudoephedrine — the kind of thing our pharmacy team would talk through with you at the counter.

What does this medicine actually do — do I need both ingredients? ▾
Yes, each ingredient does something different. Guaifenesin works on your chest — it thins and loosens the mucus in your airways so it's easier to cough up. Pseudoephedrine works on your nose and sinuses — it reduces the swelling and congestion that makes you feel stuffed up. Together they tackle both problems at once, which is why they're combined in one tablet.
Can I crush or cut the extended-release tablet if it's hard to swallow? ▾
No — please don't. Extended-release tablets are designed to release the medicine slowly over about 12 hours. Crushing, chewing, or breaking them releases the whole dose at once, which could cause stronger side effects and won't last as long. Swallow them whole with a full glass of water. If swallowing tablets is difficult, talk to your pharmacist about options.
This product has pseudoephedrine in it — will it make me feel jittery or affect my sleep? ▾
It can. Pseudoephedrine is a stimulant, and some people notice nervousness, restlessness, or trouble falling asleep — especially if they take a dose later in the day. If those side effects bother you, let your doctor know. If they're severe, stop taking the medicine and check in with a healthcare provider.
I take an antidepressant. Is it safe to use this? ▾
This is really important to check before you start. A class of antidepressants called MAOIs can cause a dangerous interaction with pseudoephedrine. Even if you stopped an MAOI within the last two weeks, you should not use this product yet. If you're not sure what type of antidepressant you take, ask your pharmacist — they can look it up quickly and tell you if it's safe.
How long before my symptoms should get better? ▾
Most people start to notice some relief within the first day or so, but the label says to give it up to 7 days. If your congestion or cough isn't improving after 7 days, or if it comes back, or if you develop a fever, skin rash, or a headache that won't quit — stop the medicine and call your doctor. Those symptoms can sometimes point to something more serious that needs a different treatment.
I'm pregnant — is this safe to take? ▾
The label advises asking a health professional before using this product during pregnancy or while breastfeeding. Please check with your OB, midwife, or pharmacist before taking it. They can weigh the risks and benefits for your specific situation and suggest the safest option for you and your baby.
Is Guaifenesin / Pseudoephedrine available over the counter? ▾
Yes — Guaifenesin / Pseudoephedrine is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Guaifenesin / Pseudoephedrine first available? ▾
Guaifenesin / Pseudoephedrine has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Guaifenesin / Pseudoephedrine? ▾
Guaifenesin / Pseudoephedrine is supplied by 45 manufacturers listed in the FDA NDC Directory, including Walgreen Company, Rite Aid Corporation, CVS Health Corp.

💬 Answers drafted from Guaifenesin / Pseudoephedrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Guaifenesin / Pseudoephedrine comes

Guaifenesin / Pseudoephedrine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Equate Mucus D Foster And Thrive Mucus Relief D Harris Teeter Mucus Relief D Health Mart mucus relief d Leader Mucus Relief D MAXIMUM STRENGTH Mucus D Mucinex D Mucus D Mucus D ER Mucus Relief D Nasal And Chest Decongestant Rugby Mucus Relief D Topcare Mucus D
How this form is used
What it may be used for
  • Helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • Temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies
  • Temporarily restores freer breathing through the nose
  • Promotes nasal and sinus drainage and temporarily relieves sinus congestion and pressure
Important instructions
  • Do not crush, chew, or break extended-release tablets — swallow them whole
  • Take with a full glass of water; may be taken with or without food
  • Adults and children 12 and older: take as directed on your specific product label (frequency and number of tablets vary by product strength)
  • Children under 12 years of age: do not use
Available strengths 2 strengths
600 mg / 60 mg 1200 mg / 120 mg
117 FDA-listed product records ⓘ

Tablet

By mouth
Brands Mucus D Mucus Relief D Mucus Relief D Sinus Congestion Poly-Vent IR Pseudo Ephed Plus
How this form is used
What it may be used for
  • Mucus Relief D: temporarily relieves sinus congestion and pressure, loosens phlegm, promotes nasal and sinus drainage, and relieves nasal congestion from cold, hay fever, or upper respiratory allergies
  • Poly-Vent IR: temporarily relieves nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy watery eyes due to the common cold, hay fever, or upper respiratory allergies; also helps loosen phlegm to make coughs more productive
Important instructions
  • Mucus Relief D (film-coated tablet): adults and children 12 and over take 1 tablet every 4 hours with a full glass of water while symptoms persist; do not exceed 6 tablets in 24 hours; children under 12 should not use
  • Poly-Vent IR: adults and children 12 and over take 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours; children 6 to under 12 may take ½ tablet every 4 hours, not to exceed 2 tablets in 24 hours; children 2 to under 6 should consult a doctor
Available strengths 5 strengths
380 mg / 60 mg 400 mg / 40 mg 200 mg / 30 mg 375 mg / 60 mg 600 mg / 60 mg
15 FDA-listed product records ⓘ

📊 Guaifenesin / Pseudoephedrine across the U.S. market

How Guaifenesin / Pseudoephedrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
45
Manufacturers
23
Brand names
132
FDA-listed product records ⓘ
2007
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Walgreen Company6%
Rite Aid Corporation6%
CVS Health Corp5%
Walgreens Company5%
Strategic Sourcing Services LLC5%
Aurohealth LLC5%
Other makers69%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Guaifenesin / Pseudoephedrine is used

A general measure of how commonly Guaifenesin / Pseudoephedrine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Guaifenesin / Pseudoephedrine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,506
Medicaid prescriptions filled (Q1–Q4 2025)
$33,125 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Guaifenesin / Pseudoephedrine prescribed? Of the 1,596 medications we measure, Guaifenesin / Pseudoephedrine ranks #1,161 by Medicaid prescriptions — more than 27% of them.

Where Guaifenesin / Pseudoephedrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,161 of 1,596
#1,156 Cytarabine 2,537 Rx #1,157 Arsenic Trioxide Injec... 2,519 Rx #1,158 Arsenic Trioxide 2,519 Rx #1,159 Dimenhydrinate 2,518 Rx #1,160 Ceftolozane and Tazoba... 2,515 Rx #1,161 Guaifenesin / Pseudoep... 2,506 Rx #1,162 Tiagabine 2,499 Rx #1,163 Oxymorphone 2,486 Rx #1,164 Fostemsavir 2,430 Rx #1,165 L-glutamine 2,400 Rx #1,166 Brentuximab Vedotin In... 2,394 Rx

Utilization by Guaifenesin / Pseudoephedrine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 600 mg / 60 mg 12 hr extended release oral tablet is the most-dispensed Guaifenesin / Pseudoephedrine product — about 99% of these Medicaid prescriptions.

12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet Most dispensed

2,482 Medicaid prescriptions (Q1–Q4 2025) 99% of Guaifenesin / Pseudoephedrine prescriptions shown $32,931 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 8 of 94 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1305603

12 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet

24 Medicaid prescriptions (Q2–Q4 2025) <1% of Guaifenesin / Pseudoephedrine prescriptions shown $194 gross reimbursement (before rebates) ≈ $8.10 per prescription (gross)

Summed across the 1 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1244675

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Guaifenesin / Pseudoephedrine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 128 listed Guaifenesin / Pseudoephedrine NDCs with Medicaid activity.

🔍 Compare Guaifenesin / Pseudoephedrine products

A representative set of FDA-listed product records for Guaifenesin / Pseudoephedrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 132 of 132 products — FDA National Drug Code Directory. See every product, package size and price: browse all 132 Guaifenesin / Pseudoephedrine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Guaifenesin / Pseudoephedrine RxCUI 214599 4 dose forms · 16 strengths
  2. Dose form (SCDF) Oral Capsule RxCUI 373687 No current FDA listing
    Clinical drug / strength (SCD) guaifenesin 150 MG / pseudoephedrine hydrochloride 30 MG RxCUI 1298405 guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG RxCUI 1090482
  3. Dose form (SCDF) Oral Solution RxCUI 373689 No current FDA listing
    Clinical drug / strength (SCD) guaifenesin 20 MG/ML / pseudoephedrine hydrochloride 6 MG/ML RxCUI 1089775 guaifenesin 50 MG/ML / pseudoephedrine hydrochloride 7.5 MG/ML RxCUI 1099634
  4. Dose form (SCDF) Oral Tablet RxCUI 373691 In current FDA listings
    Clinical drug / strength (SCD) guaifenesin 190 MG / pseudoephedrine hydrochloride 30 MG RxCUI 1094003 guaifenesin 360 MG / pseudoephedrine hydrochloride 60 MG RxCUI 2003123 guaifenesin 375 MG / pseudoephedrine hydrochloride 60 MG RxCUI 1148644 guaifenesin 380 MG / pseudoephedrine hydrochloride 60 MG RxCUI 1426579 guaifenesin 400 MG / pseudoephedrine hydrochloride 20 MG RxCUI 1593149 guaifenesin 400 MG / pseudoephedrine hydrochloride 30 MG RxCUI 1300020 guaifenesin 400 MG / pseudoephedrine hydrochloride 40 MG RxCUI 1090623 guaifenesin 400 MG / pseudoephedrine hydrochloride 60 MG RxCUI 1298443

Look up RxCUI 214599 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Mucus Relief D Mucus D Mucinex D equate mucus d Poly-Vent IR foster and thrive mucus relief d leader mucus relief d Mucus Relief D Sinus Congestion TopCare Mucus D rugby mucus relief d Mucus D ER Health Mart mucus relief d Pseudo Ephed Plus Harris Teeter Mucus Relief D MAXIMUM STRENGTH Mucus D nasal and chest decongestant

🏭 Manufacturers & labelers

Walgreen Company 8 Rite Aid Corporation 7 CVS Health Corp 6 Walgreens Company 6 Strategic Sourcing Services LLC 6 Aurohealth LLC 6 Walgreen Co. 5 A-S Medication Solutions 5 Meijer Distribution Inc 5 Granules India Ltd 4 Cardinal Health 110, LLC. dba Leader 4 Ohm Laboratories, Inc. 4 Dr. Reddys Laboratories Limited 4 Strategic Sourcing Services, LLC 4 Kroger Company 4 Meijer, Inc. 3 H E B 3 Wal-mart Stores, Inc. 3 Poly Pharmaceuticals, Inc. 3 Walmart Inc. 3 Rugby Laboratories 3 Cvs Woonsocket Prescription Center, Incorporated 2 Aurobindo Pharma Limited 2 L. Perrigo Company 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Guaifenesin / Pseudoephedrine belongs to the Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 27, 2018
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Guaifenesin / Pseudoephedrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Guaifenesin / Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
54
NDC products indexed
132
Distinct labelers/manufacturers represented
45
Linked representative label ⓘ
Walgreen Company
Linked label effective
Oct 27, 2018
Composite sections available
7
Linked SPL Set ID
310d14be-e7ea-44b8-8b04-cffa39440d50
Linked SPL Document ID
23bd928b-a15a-4da4-80c3-c599113f8376
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 54 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Walgreen Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.