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Tussnex FM Severe cough and congestion Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid, 177 mL

by Guardian Drug Company · 177 mL in 1 BOTTLE (53041-617-58)
NDC 53041-0617-58
🏷️ FDA NDC (as labeled) 53041-617-58 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 53041-617-58
Product NDC 53041-617
11-digit billing NDC 53041061758
RxCUI 1043543
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0053041617584
Application # M012
SPL Set ID 387df403-7803-4031-915e-8de9b103a162
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-12-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 53041-617-58 — 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 → 53041-0617-58. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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

LabelerGuardian Drug Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53041
First marketedDec 2012
Product typeHuman Otc Drug
Portfolio46 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 is this product?

Tussnex FM Severe is an over-the-counter liquid medicine taken by mouth that contains three active ingredients commonly used to manage cough and congestion symptoms. Dextromethorphan is a cough suppressant, while guaifenesin functions as an expectorant to help thin mucus. Phenylephrine is a decongestant typically used to relieve nasal and sinus congestion. This product is marketed under FDA's over-the-counter monograph rules for cough and cold medicines.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer 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
Leader Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 70000-0629-01 CARDINAL 1 bottle $0.047 — Availability likely —
Mucinex Fast-Max Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0540-66 Reckitt 180 ml $0.060 — FDA listed —
Mucinex Childrens Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0949-01 Reckitt 1 bottle $0.070 — FDA listed —
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0956-64 Reckitt 1 bottle $0.070 — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0337-06 Walgreens 177 ml — — FDA listed —
Mucus Congestion and Cough Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-0512-06 Walgreens 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0681-06 Walgreens 177 ml — — FDA listed —
Childrens Mucus Cough and Congestion Relief 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-1056-88 Walgreen 1 bottle — — FDA listed —
Walgreen Maximum Strength Severe Congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7389-09 WALGREENS 266 ml — — FDA listed —
Walgreens Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7760-06 WALGREEN 180 ml — — FDA listed —
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-8004-45 Walgreen 177 ml — — FDA listed —
Childrens Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-9057-36 Walgreen 1 bottle — — FDA listed —
Mucus Relief Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0337-06 TARGET 177 ml — — FDA listed —
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0738-06 Target 177 ml — — FDA listed —
SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 21130-0162-04 SAFEWAY 1 bottle — — FDA listed —
Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0738-06 SAFEWAY 180 ml — — FDA listed —
Kroger Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 30142-0738-06 KROGER 180 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 36800-0037-06 TOP 177 ml — — FDA listed —
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 37808-0317-25 H 177 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0047-06 United 177 ml — — FDA listed —
maximum strength mucus relief severe congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0738-06 SuperValu 180 ml — — FDA listed —
Childrens Multi-Symptom Cold 5 mg/5mL; 2.5 mg/5mL; 100 mg/5mL 41226-0937-05 Kroger 1 bottle — — FDA listed —
Meijer Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0446-06 MEIJER, 180 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough Cooling Menthol 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0776-06 MEIJER 180 ml — — FDA listed —
Childrens Multi-symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 49035-0715-03 Wal-Mart 118 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0774-06 Wal-Mart 180 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0976-06 Wal-Mart 180 ml — — FDA listed —
Tukol MAX ACTION Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50066-0517-25 Genomma 177 ml — — FDA listed —
Severe Congestion and Cough Relief Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50844-0004-45 L.N.K. 177 ml — — FDA listed —
Childrens Multi Symptom Cold Very Berry 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 51316-0815-03 CVS 118 ml — — FDA listed —
Childrens Tussnex Multi-symptom cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 53041-0615-03 Guardian 1 bottle — — FDA listed —
Tussnex FM Severe cough and congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mLthis 53041-0617-58 Guardian 177 ml — — FDA listed —
Mucosan Severe Multi-Symptom 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 53145-0697-06 Menper 1 bottle — — FDA listed —
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53942-0517-25 DeMoulas 177 ml — — FDA listed —
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53943-0517-25 Discount 177 ml — — FDA listed —
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55319-0204-45 Family 177 ml — — FDA listed —
SanaTos Turbo Max Strength 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 55758-0322-06 Pharmadel 177 ml — — FDA listed —
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0037-09 Dolgencorp, 266 ml — — FDA listed —
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0537-06 Dolgencorp, 177 ml — — FDA listed —
Childrens Mucinex Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0282-22 Reckitt 1 cello — — Discontinued —
Mucinex Childrens Cough and Congestion 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0947-11 Reckitt 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63868-0745-06 QUALITY 177 ml — — FDA listed —
Severe Congestion and Cough Max 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63941-0517-25 Best 177 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 68163-0738-09 Raritan 266 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69256-0337-06 Harris 177 ml — — FDA listed —
Cold Childrens, Multi Symptom 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0570-88 CVS 1 bottle — — FDA listed —
Congestion and Cough Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0756-88 CVS 1 bottle — — FDA listed —
CVS Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0767-06 CVS 180 ml — — FDA listed —
Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0942-45 CVS 177 ml — — FDA listed —
AMAZON Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 72288-0649-04 AMAZON.COM 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0040-45 TOPCO 177 ml — — FDA listed —
Mucus Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 76162-0057-88 TOPCO 1 bottle — — FDA listed —
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76281-0517-25 AptaPharma 177 ml — — FDA listed —
Multi-Symptom Cold childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0176-06 WALMART 1 bottle — — FDA listed —
Childrens Multi-symptom Cold Daytime 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0270-03 Wal-Mart 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0077-06 Chain 177 ml — — FDA listed —
QCH Maximum Strength Mucus Relief 617 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0144-06 Chain 177 ml — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 42507-0617-58 Hyvee 177 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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
Dec 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Tussnex FM Severe cough and congestion (this brand).

Top reported reactions

Cough2
Fatigue1
Insomnia1
Pain1
Pyrexia1
Sinusitis1
Vertigo1

Age at onset

Adult1

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 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
53041-0617-58 You're viewing this 177 mL in 1 BOTTLE (53041-617-58) 2012-12-01 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 53041-617-58, 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: 53041-0617-58, written without dashes as 53041061758. 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 53041-0617-58, the first segment (53041) is the labeler code FDA assigned to Guardian Drug Company; the middle segment (0617) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) 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 Guardian Drug Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guardian Drug Company 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 58 words ▾

Uses hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

⏱️ Dosage and Administration 59 words ▾

Directions do not take more than 6 doses in 24-hour period measure only with dosing coup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours Children under 12 years of age: Do not use

⚠️ Warnings 191 words ▾

Warnings Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with rash or persistent headache.

These could be signs of a serious condition. 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.

📦 Storage and Handling 22 words ▾

Other information each 20 mL contains: sodium 20 mg store between 15-30 o C(59-86 o F) do not refrigerate dosing cup provided

🧪 Active Ingredient 17 words ▾

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

🎯 Purpose 6 words ▾

Purpose Cough suppressant Expectorant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53041-0616-58 · Guardian 53041-0618-58 · Guardian →
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.