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Childrens Tussnex Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg/10mL; 10 mg/10mL; 5 mg/10mL; 200 mg/10mL Liquid — NDC 53041-622-03 (Billing 53041-0622-03)

by Guardian Drug Company · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Childrens Tussnex Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg/10mL; 10 mg/10mL; 5 mg/10mL; 200 mg/10mL Liquid from Guardian Drug Company, marketed since May 2012 and currently FDA-listed. It is this product's only package size.

NDC 53041-0622-03
🏷️ FDA NDC (as labeled) 53041-622-03 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53041-622-03
Product NDC 53041-622
11-digit billing NDC 53041062203
RxCUI 1593450
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ, 495W7451VQ
Application # M012
SPL Set ID 19e9678d-ac34-4af8-a80f-d08fce0a5f0e
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 2012-05-05
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 1593450
Why two NDCs? The FDA registers this code as 53041-622-03 — 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 → 53041-0622-03. 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 Anilides class.

Drug family (ATC) Anilides
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.

Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Childrens Tussnex is an oral liquid cold and cough product marketed as an OTC monograph drug. It contains four active ingredients that work together to address different cold symptoms. Acetaminophen is a pain reliever and fever reducer, while dextromethorphan is a cough suppressant. Guaifenesin functions as an expectorant to help thin mucus, and phenylephrine is a decongestant typically used to relieve nasal congestion. This combination is commonly used to manage multiple cold symptoms in children.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53041-0622-03 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2012-05-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Multi-symptom Cold and Fever Liquid 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 49035-0772-03 Wal-Mart 1 bottle — — FDA listed —
Childrens Tussnex 325 mg/10mL; 10 mg/10mL; 5 mg/10mL; 200 mg/10mLthis 53041-0622-03 Guardian 1 bottle — — FDA listed —
SanaTos X 20 mg/1; 650 mg/1; 400 mg/1; 10 mg 55758-0311-06 Pharmadel 1 bottle — — FDA listed —
Rompe Pecho Max Multi Symptoms 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 58593-0828-08 EFFICIENT 1 bottle — — FDA listed —
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 76281-0519-24 AptaPharma 1 bottle — — 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
May 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.

What it looks like

Color blue
FlavorBerry
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.

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.

Manufacturer & labeler

LabelerGuardian Drug Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53041
First marketedMay 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.

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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 64 words ▾

Uses temporarily relieves these common cold and flu symptoms: nasal congestion stuffy nose cough due to minor throat and minor bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

⏱️ Dosage and Administration 106 words ▾

Directions this product does not contain directions or complete warnings for adult dose do not take more than directed (see overdose warning) shake well before use do not take more than 5 doses in any 24 hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Children 6 to under 12 years of age: 10 mL in dosing cup provided Children under 6 years of age: Do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is maximum daily amount with other drugs containing acetaminophen Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, 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 giving this product. Ask a doctor before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache.

These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🆘 Overdosage 56 words ▾

Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 23 words ▾

Other information each 10 mL contains : sodium 10 mg store between 15-30 o C(59-86 o F) do not refrigerate dosing cup provided

🧪 Active Ingredient 20 words ▾

Active ingredients (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients citric acid anhydrous, edetate disodium, FD and 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 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use ~1 min read ▾

Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, 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 giving this product.

Ask a doctor before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache.

These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Ask a Doctor Before Use If 190 words ▾

Ask a doctor before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache.

These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Ask a Doctor or Pharmacist Before Use If 142 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 When Using This Product 126 words ▾

When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Stop Use and Ask a Doctor If 116 words ▾

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Package Label / Principal Display Panel 52 words ▾

PDP Compare to the active ingredients in Mucinex Childrens Multi-symptom Cold and Fever Childrens Tussnex Multi symptom Cold and Fever Acetaminophen Pain reliever / Fever Reducer Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Phenylephrine HCl Nasal Decongestant Relieves Nasal and chest congestion Thins and loosens mucus Reduces fever Soothes cough Alcohol Free SN

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 53041-0618-58 · Guardian 53041-0628-58 · 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.