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(from DailyMed)

Mucus Relief DM Guaifenesin, Dextromethorphan HBr 600 mg; 30 mg Tablet, 20-count

by CARDINAL HEALTH 110, LLC. DBA LEADER 70000 · 20 BLISTER PACK in 1 CARTON (70000-0491-1) / 1 TABLET in 1 BLISTER PACK
NDC 70000-0491-01
🏷️ FDA NDC (as labeled) 70000-0491-1 billing pads the package segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70000-0491-1
Product NDC 70000-0491
11-digit billing NDC 70000049101
NCPDP billing unit EA — each (per item)
RxCUI 1298324
UNII 495W7451VQ, 9D2RTI9KYH
UPC 0096295136890
Application # ANDA209692
SPL Set ID e24fd894-5dee-4f46-aafa-fbf9f0b166fd
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2019-01-31
Marketing end 2026-08-28
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
GPI-14 43997002527430
GPI class Mucus Relief DM
GCN Seq No 012074
GCN 53550
HICL code 000223
Ingredient (HICL) Guaifenesin/Dextromethorphan
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3T
Therapeutic class — specific (HIC3) Non-Opioid Antitussive And Expectorant Combination
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name MUCUS RLF DM ER 600-30 MG TAB
FDB brand name Mucus Relief Dm Er
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0491-1 — a 5-4-1 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 package segment → 70000-0491-01. 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

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA209692 (ANDA)
Labeler code70000
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio17 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

Label name MUCUS RLF DM ER 600-30 MG TAB Ingredient Guaifenesin/Dextromethorphan
📗 Our plain-language guide HelloPharmacist
  • The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
  • What exactly does this combination do — why are two ingredients needed?
  • It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
  • Can I take this if I'm on an antidepressant?
📖 Read our full Dextromethorphan / Guaifenesin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 eaPer package
Retail pharmacies payNADAC · weekly $0.359 $7.18 / 20 tablet
Medicaid paysCMS SDUD · 12 mo $0.7071 $14.14 / 20 tablet
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.495 $0.348
▼ Down 15% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 00536-1161-34 Rugby 20 tablets $0.359 Availability likely
Rugby Mucus Relief DM ER 30 mg/1; 600 mg 00536-1446-34 Rugby 20 tablets $0.359 Availability likely
Good Neighbor Pharmacy Mucus Dm 30 mg/1; 600 mg 46122-0817-61 Amerisource 20 tablets $0.359 Availability likely
Mucus Relief DM 600 mg/1; 30 mgthis 70000-0491-01 CARDINAL 20 tablets $0.359 Discontinued
Leader Mucus Relief DM 30 mg/1; 600 mg 70000-0722-01 Cardinal 20 tablets $0.359 Availability likely
Mucus Relief DM 600 mg/1; 30 mg 70677-1050-01 Strategic 1 tablet $0.359 Availability likely
Mucinex DM 600 mg/1; 30 mg 63824-0056-01 Reckitt 20 tablets $0.608 Discontinued +69%
Good Sense Mucus DM 30 mg/1; 600 mg 00113-2219-01 L. 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 00363-0474-01 WALGREEN 10 tablets FDA listed
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 00363-0733-20 Walgreens 20 tablets FDA listed
Mucus Relief DM 30 mg/1; 600 mg 00363-3219-01 Walgreen 20 tablets FDA listed
up and up mucus relief dm 30 mg/1; 600 mg 11673-0716-01 Target 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 11822-0733-02 Rite 20 tablets FDA listed
mucus relief DM 30 mg/1; 600 mg 11822-2219-00 Rite 20 tablets FDA listed
Mucus Relief DM Extended Release Caplets 600 mg/1; 30 mg 17856-1162-01 ATLANTIC 1 tablet FDA listed
Mucus Relief Dm 600 mg/1; 30 mg 21130-0997-67 Better 10 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 30142-0276-20 KROGER 10 tablets FDA listed
Guaifenesin And Dextromethorphan Hbr 600 mg/1; 30 mg 30142-0948-20 Kroger 20 tablets FDA listed
Topcare Mucus DM 30 mg/1; 600 mg 36800-0219-01 Topco 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 37808-0733-40 H 40 tablets FDA listed
equaline mucus dm 30 mg/1; 600 mg 41163-0599-01 United 20 tablets FDA listed
mucus relief dm 30 mg/1; 600 mg 41250-0436-01 Meijer 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 41415-0998-20 PUBLIX 20 tablets FDA listed
Mucus Dm 30 mg/1; 600 mg 42507-0222-20 HyVee 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 43598-0114-01 Dr. 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 43598-0231-01 Dr. 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 49035-0960-12 Wal-Mart 40 tablets FDA listed
Mucinex Dm 600 mg/1; 30 mg 50090-1077-00 A-S 20 tablets FDA listed
Mucinex DM 600 mg/1; 30 mg 50090-1078-00 A-S 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBR 600 mg/1; 30 mg 51316-0009-01 CVS 20 tablets FDA listed
Cough And Congestion Extended Release 600 mg/1; 30 mg 51316-0065-67 CVS 10 tablets FDA listed
Mucus Relief Dm 30 mg/1; 600 mg 51316-0858-78 CVS 100 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 51660-0301-21 OHM 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 55910-0733-06 Dolgencorp, 6 tablets FDA listed
DG health mucus dm 30 mg/1; 600 mg 55910-0746-01 Dolgencorp 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0714-05 Aurohealth 14 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0824-08 Aurohealth 10 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 58602-0871-83 Aurohealth 10 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 59726-0733-06 P 6 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 60000-0058-67 Ahold 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 63304-0106-21 SUN 20 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 63941-0733-20 Best 20 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 65162-0038-03 Amneal 30 tablets FDA listed
Mucinex DM, TRAVEL BASIX 600 mg/1; 30 mg 66715-6424-01 Lil' 2 tablets FDA listed
Mucinex DM, CVP HEALTH 600 mg/1; 30 mg 66715-6524-01 Lil' 2 tablets FDA listed
Mucinex DM 600 mg/1; 30 mg 66715-9724-01 Lil' 2 tablets FDA listed
Mucus Relief DM Expectorant and Cough Suppressant 600 mg/1; 30 mg 67091-0314-20 Winco 10 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 67091-0344-20 WinCo 20 tablets FDA listed
Mucinex DM 30 mg/1; 600 mg 67751-0171-01 Navajo 2 tablets FDA listed
Mucus DM Extended Release 600 mg/1; 30 mg 69842-0057-11 CVS 10 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 69842-0933-20 CVS 20 tablets Discontinued
mucus dm extended release 30 mg/1; 600 mg 69842-0963-01 CVS 20 tablets FDA listed
Mucus Relief Dm 600 mg/1; 30 mg 72036-0012-20 Harris 10 tablets FDA listed
basic care mucus dm 30 mg/1; 600 mg 72288-0219-49 Amazon.com 40 tablets FDA listed
Amazon Basic Care Mucus Dm 600 mg/1; 30 mg 72288-0220-08 Amazon.com 10 tablets FDA listed
Mucus Relief DM 600 mg/1; 30 mg 72476-0733-20 Care 20 tablets FDA listed
equate mucus relief dm 30 mg/1; 600 mg 79903-0065-01 WALMART 20 tablets FDA listed
Mucinex DM 600 mg/1; 30 mg 85237-1650-01 Select 2 tablets FDA listed
Guaifenesin and Dextromethorphan HBr 600 mg/1; 30 mg 85766-0150-14 Sportpharm 14 tablets FDA listed
Good Sense Mucus DM 30 mg/1; 600 mg 85766-0172-20 Sportpharm 20 tablets FDA listed
Mucinex DM 600 mg/1; 30 mg 85766-0176-20 Sportpharm 20 tablets FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0491-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.1K
Units reimbursed last 4 qtrs
95.8K
Gross reimbursed last 4 qtrs
$67.7K
Avg / prescription
$21.68
Avg / unit
$0.7071
Latest quarter Q4 2025
511Rx
Medicaid pays / ea
$0.7071
gross reimbursed
vs
NADAC / ea
$0.3591
acquisition cost
=
Spread
+$0.3480
+97% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
71% FFS 29% MCO
Fee-for-service · 2,212 Rx Managed care · 912 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 71,776 units · 367 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,958 units · 16.6 per 100k residents OH Pennsylvania: 5,880 units · 45.4 per 100k residents PA New Jersey: 1,928 units · 20.8 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 7,289 units · 161 per 100k residents KY West Virginia: 596 units · 33.7 per 100k residents WV Virginia: 770 units · 8.8 per 100k residents VA Maryland: 286 units · 4.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 222 units · 2.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,096 units · 16.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.0367
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 367 /100k
2 Kentucky 161 /100k
3 Pennsylvania 45.4 /100k
4 West Virginia 33.7 /100k
5 New Jersey 20.8 /100k
6 Texas 16.7 /100k
7 Ohio 16.6 /100k
8 Virginia 8.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Mucus Relief DM (this brand).

Top reported reactions

Diarrhoea17
Nausea11
Covid-1910
Dyspnoea9
Dizziness8
Vomiting8
Disease Recurrence7

Age at onset

Adolescent1
Adult3
Elderly4

Reporter sex

162 reports
Male · 49%
Female · 51%

Serious outcomes

Hospitalization30
Death17
Life-threatening3
Disabling2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 36 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
70000-0491-01 You're viewing this 20 BLISTER PACK in 1 CARTON (70000-0491-1) / 1 TABLET in 1 BLISTER PACK 2019-01-31 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 70000-0491-1, 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: 70000-0491-01, written without dashes as 70000049101. 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 70000-0491-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER 70000; the middle segment (0491) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000 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 56 words

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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

⏱️ Dosage and Administration 59 words

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regards for timing of meals adults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use

⚠️ Warnings 164 words

Warnings Do not use for children under12 years of age if you are now 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 taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product, do not use more than directed.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. If 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 (1-800-222-1222).

🧪 Active Ingredient 13 words

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 30 mg Guaifenesin 600 mg

🧪 Inactive Ingredients 19 words

Inactive ingredients carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

🎯 Purpose 4 words

Purpose Cough Suppressant Expectorant

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