FDA-filed SPL labeling · retrieved through openFDA

Guaifenesin

Guaifenesin is an expectorant used across many oral products to loosen chest congestion and thin mucus, making coughs more productive.

Brand names Smart Sense TussinMucus Relief ChestMucus ReliefOrgan-i NrPremier Value Chest Congestion Relief +11 more
Drug class ⓘ Expectorant
Rx/OTC Forms 5 Routes Oral · Topical
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 324 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 effectiveDec 18, 2017
Clinical labels in scope ⓘ324
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1986
FDA-listed product records ⓘ801
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Guaifenesin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Guaifenesin is a widely available expectorant that helps thin and loosen chest mucus so you can cough it up more easily. It's best for short-term congestion relief — if symptoms stick around beyond 7 days or come with fever or a rash, that's a signal to check with your doctor. Always swallow extended-release tablets whole and drink plenty of water.
How we write & review this content — our editorial policy →

📖 Guaifenesin: Patient Information Guide

A plain-language walkthrough of Guaifenesin — 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 is an expectorant used across many products to relieve chest congestion. Here is what it is used for:

  • Loosening phlegm (mucus) in the chest and airways to make it easier to cough up
  • Thinning bronchial secretions (the sticky fluid in your breathing passages) to clear congestion
  • Making coughs more productive so mucus is expelled rather than just irritating your throat
💊How it's taken▾

Guaifenesin comes in several forms — regular tablets, oral solutions, and extended-release tablets — taken by mouth. Extended-release tablets (such as 12 Hour Mucus Relief, 365 Whole Foods Market Guaifenesin, basic care mucus er, basic care mucus er max, DG health mucus er max, and Dr. Simi Mucus Relief) are generally taken about every 12 hours and can be taken with or without food.

  • Extended-release tablets must be swallowed whole — never crush, chew, or break them
  • Always take extended-release tablets with a full glass of water
  • Extended-release tablet forms are for adults and children 12 and over only
  • For oral solutions (such as Childrens Mucus Relief and Tussin), follow the directions on your specific product label
🤒Side effects — in detail▾

The FDA labels for guaifenesin products do not list specific common side effects. However, watch for these warning signs that mean you should stop and call a doctor:

  • Cough that lasts more than 7 days or keeps coming back
  • Cough accompanied by fever, rash, or a persistent headache
  • Signs of an allergic reaction or hypersensitivity to any ingredient
⚠️Warnings & precautions▾
  • Limit use to short-term relief: If your cough hasn't improved after 7 days, returns after getting better, or comes with fever, rash, or a lasting headache, stop the medication and see a doctor — these can be signs of a serious condition.
  • Ask a doctor before use if you have a chronic cough from smoking, asthma, chronic bronchitis, or emphysema, or a cough that produces a lot of mucus.
  • Guaifenesin can interfere with certain laboratory tests (5-HIAA and VMA urine tests). Let any healthcare provider know you are taking it before lab work.
  • If pregnant or breastfeeding, ask a health professional before use.
  • Keep all medications out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
🔀What it interacts with▾

The FDA labels for guaifenesin products do not identify specific drug or food interactions. However, one important note for healthcare providers:

  • Guaifenesin can cause a color interference with certain urine lab tests — specifically tests measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA) — which may produce a false or misleading result. Always tell your doctor or lab that you are taking guaifenesin before these tests.

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▾
  • Ask a doctor first if you have a cough that produces a lot of mucus.
  • Ask a doctor first if your cough is chronic — for example, related to smoking, asthma, chronic bronchitis, or emphysema.
  • If you are pregnant or breastfeeding, check with a health professional before taking any guaifenesin product.
  • Extended-release tablet forms are not appropriate for children under 12 years of age.
  • Stop use and ask a doctor if you have any signs of hypersensitivity (allergic reaction) to an ingredient.
🚑If you take too much▾

In case of overdose, get medical help or contact a Poison Control Center right away. Do not wait for symptoms to appear before seeking help.

📦How to store it▾

store at room temperature do not refrigerate dosing cup provided

📄 Written from Guaifenesin’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 →

26

Supplements & herbs that interact with Guaifenesin

26 supplements and herbal products have documented interactions with Guaifenesin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 15
  • Minor · 9
ACTIVATED CHARCOAL Major GRAPEFRUIT Major BERBERINE Moderate BITTER ORANGE Moderate COFFEE CHARCOAL Moderate CORYDALIS YANHUSUO Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate +18 more
Every supplement checked against Guaifenesin — ranked by severity The full interaction hub: 2 major · 15 moderate · 9 minor · every one linked to its full report. Check Guaifenesin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What exactly does guaifenesin do for my cough? ▾
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 instead of a dry, unproductive cough, you're actually clearing something. It doesn't suppress your cough; it makes your cough do its job better.
How long can I take it before I should call my doctor? ▾
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, stop taking it and call your doctor. Those can be signs of something more serious that needs a proper diagnosis — not just more cough medicine.
Can I crush or split my extended-release guaifenesin tablet to make it easier to swallow? ▾
No — please don't. Extended-release tablets are specially designed to release the medication slowly over about 12 hours. Crushing, chewing, or breaking them destroys that mechanism and can release too much at once. Swallow the tablet whole with a full glass of water. If swallowing tablets is a challenge, talk to your pharmacist — there are liquid options like Tussin or Childrens Mucus Relief that might work better for you.
Do I need to take it with food? ▾
For extended-release tablets, food doesn't matter — you can take them with or without a meal. Just make sure to drink a full glass of water with every dose. Staying well hydrated in general also helps thin mucus, so drink plenty of fluids throughout the day while you're using it.
Is it safe to take if I'm pregnant or breastfeeding? ▾
The labeling says to ask a health professional before using any guaifenesin product if you're pregnant or breastfeeding. That's the safe call — check with your OB or midwife first before taking it, just to make sure it's the right choice for your situation.
I have a lab test coming up. Does guaifenesin affect lab results? ▾
Yes, and this is worth knowing. Guaifenesin can interfere with certain urine lab tests — specifically ones that measure substances called 5-HIAA and VMA. It can cause a false or misleading result. Make sure to tell your doctor or the lab that you're taking guaifenesin before any urine testing, so they can account for it.
Is Guaifenesin available over the counter? ▾
Both — Guaifenesin is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Guaifenesin first available? ▾
Guaifenesin has been available in the United States since at least 1986, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Guaifenesin? ▾
Guaifenesin is supplied by 229 manufacturers listed in the FDA NDC Directory, including Strategic Sourcing Services LLC, Bryant Ranch Prepack, Rite Aid Corporation.

💬 Answers drafted from Guaifenesin’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

📊Guaifenesin supplement interactions26 checked — ranked by severity 🌿Drug & Supplement CheckerGuaifenesin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Guaifenesin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Guaifenesin comes

Guaifenesin is available in 5 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.

Tablet

By mouth
Brands Mucus Relief
How this form is used
What it may be used for
  • Helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Important instructions
  • Take by mouth as directed on your product label
  • Follow your prescriber's guidance on how often to take it
Available strengths 5 strengths
100 mg 200 mg 400 mg 600 mg 1200 mg
307 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Mucinex Mucus Relief
How this form is used
What it may be used for
  • Helps loosen phlegm and thin bronchial secretions to make coughs more productive
Important instructions
  • Do not crush, chew, or break the extended-release tablet — swallow it whole
  • Take with a full glass of water
  • Can be taken with or without food
  • For adults and children 12 and over only — do not give to children under 12
Available strengths 3 strengths
600 mg 1200 mg 1 kg/kg
296 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Siltussin SA Sunmark Tussin Topcare Tussin
How this form is used
What it may be used for
  • Helps loosen phlegm and thin bronchial secretions to rid the airways of bothersome mucus and make coughs more productive
Important instructions
  • Take by mouth as directed on the product label
  • Follow your prescriber's or pharmacist's guidance on frequency and amount
Available strengths 6 strengths
100 mg/5 mL 200 mg/5 mL 200 mg/10 mL 300 mg/15 mL 400 mg/10 mL 400 mg/20 mL
174 FDA-listed product records ⓘ

Oral powder

By mouth
Available strengths 1 strength
100 mg
2 FDA-listed product records ⓘ

Topical solution

On the skin
Available strengths 1 strength
100 mg/5 mL
1 FDA-listed product record ⓘ

📊 Guaifenesin across the U.S. market

How Guaifenesin 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.

5
Dose forms ⓘ
229
Manufacturers
40
Brand names
801
FDA-listed product records ⓘ
1986
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.

Also listed with the FDA, not a patient dose form: Powder (18) · Granule (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Strategic Sourcing Services LLC6%
Bryant Ranch Prepack4%
Rite Aid Corporation4%
Spirit Pharmaceuticals Llc4%
Aurohealth LLC4%
A-S Medication Solutions4%
Other makers74%

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

📈 How widely Guaifenesin is used

A general measure of how commonly Guaifenesin 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 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.

701,387
Medicaid prescriptions filled (Q1–Q4 2025)
$9.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Guaifenesin prescribed? Of the 1,596 medications we measure, Guaifenesin ranks #220 by Medicaid prescriptions — more than 86% of them.

Where Guaifenesin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #220 of 1,596
#215 Sucralfate 724,768 Rx #216 Ketotifen Ophthalmic 714,559 Rx #217 Ketotifen 714,559 Rx #218 Metoclopramide 712,920 Rx #219 Ofloxacin Otic 706,749 Rx #220 Guaifenesin 701,387 Rx #221 Hydroxychloroquine 696,525 Rx #222 Paliperidone Injection 691,208 Rx #223 Sitagliptin 688,306 Rx #224 Ethinyl Estradiol / Le... 668,771 Rx #225 Mometasone 666,398 Rx

Utilization by Guaifenesin 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 12 hr extended release oral tablet is the most-dispensed Guaifenesin product — about 45% of these Medicaid prescriptions.

12 HR guaifenesin 600 MG Extended Release Oral Tablet Most dispensed

318,858 Medicaid prescriptions (Q1–Q4 2025) 45% of Guaifenesin prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 18 of 257 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636522

guaifenesin 20 MG/ML Oral Solution

244,208 Medicaid prescriptions (Q1–Q4 2025) 35% of Guaifenesin prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $9.92 per prescription (gross)

Summed across the 17 of 137 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310604

guaifenesin 400 MG Oral Tablet

109,762 Medicaid prescriptions (Q1–Q4 2025) 16% of Guaifenesin prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 8 of 158 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 359601

guaifenesin 200 MG Oral Tablet

12,166 Medicaid prescriptions (Q1–Q4 2025) 2% of Guaifenesin prescriptions shown $151,168 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 1 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197741

12 HR guaifenesin 1200 MG Extended Release Oral Tablet

11,800 Medicaid prescriptions (Q1–Q4 2025) 2% of Guaifenesin prescriptions shown $199,291 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 14 of 211 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310621

guaifenesin 20 MG/ML Oral Suspension

4,593 Medicaid prescriptions (Q1–Q4 2025) <1% of Guaifenesin prescriptions shown $59,284 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1606850

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, 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 61 of 785 listed Guaifenesin NDCs with Medicaid activity.

🔍 Compare Guaifenesin products

A representative set of FDA-listed product records for Guaifenesin — 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 200 of 801 products — FDA National Drug Code Directory. See every product, package size and price: browse all 801 Guaifenesin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Guaifenesin RxCUI 5032 7 dose forms · 20 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 866448 No current FDA listing
    Clinical drug / strength (SCD) 100 MG RxCUI 866449
  3. Dose form (SCDF) Oral Capsule RxCUI 372357 No current FDA listing
    Clinical drug / strength (SCD) 200 MG RxCUI 198689 300 MG RxCUI 237248
  4. Dose form (SCDF) Oral Granules RxCUI 647406 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 647407
  5. Dose form (SCDF) Oral Solution RxCUI 372358 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 636574 20 MG/ML RxCUI 310604 40 MG/ML RxCUI 310625 50 MG/ML RxCUI 249709
  6. Dose form (SCDF) Oral Suspension RxCUI 439943 No current FDA listing
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 1606850
  7. Dose form (SCDF) Oral Tablet RxCUI 372360 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 198687 200 MG RxCUI 197741 400 MG RxCUI 359601 575 MG RxCUI 391958 600 MG RxCUI 391865 675 MG RxCUI 391955 800 MG RxCUI 392085 1000 MG RxCUI 349397 1200 MG RxCUI 349369

Look up RxCUI 5032 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

Smart Sense Tussin Mucus Relief Chest Mucus Relief Organ-i Nr Premier Value Chest Congestion Relief Q-Tussin Refenesen Chest Congestion Relief Robitussin Chest Congestion Scot-Tussin Expectorant SF Cough SelectHealth Tussin DM Siltussin DAS Siltussin SA Mucinex Sunmark Tussin Topcare Mucus Relief Topcare Tussin

🏭 Manufacturers & labelers

Strategic Sourcing Services LLC 23 Bryant Ranch Prepack 16 Rite Aid Corporation 15 Spirit Pharmaceuticals Llc 15 Aurohealth LLC 15 A-S Medication Solutions 15 Granules India Ltd 14 CVS Pharmacy 14 Rugby Laboratories 12 Walgreen Company 11 Geri-Care Pharmaceuticals, Corp 11 Major Pharmaceuticals 11 Cardinal Health 107, LLC 11 Dr. Reddy's Laboratories Inc. 10 Topco Associates Llc 10 Yyba Corp 10 Amerisource Bergen 10 Health Pharma USA LLC 10 Pioneer Life Sciences, LLC 9 P & L Development, LLC 9 Little Pharma, Inc. 8 Remedyrepack Inc. 8 L. Perrigo Company 8 Reese Pharmaceutical Co 8

…and 16 more on the FDA NDC directory.

RxNorm drug class

Guaifenesin 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 Dec 18, 2017
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Guaifenesin.
📈
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 after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
324
NDC products indexed
801
Distinct labelers/manufacturers represented
229
Linked representative label ⓘ
Aphena Pharma Solutions - Tennessee, LLC
Linked label effective
Dec 18, 2017
Composite sections available
8
Linked SPL Set ID
1c84bf00-ebaa-4e69-a2c6-716631d209d9
Linked SPL Document ID
cc734890-e42c-454a-b771-3ecd169d161a
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 324 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. Aphena Pharma Solutions - Tennessee, LLC 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.