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Maximum Strength Guaifenesin DM Guaifenesin, Dextromethorphan HBr 60 mg; 1200 mg Tablet, Extended Release, 14-count — NDC 00536-1213-88 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Maximum Strength Guaifenesin DM Guaifenesin, Dextromethorphan HBr 60 mg; 1200 mg Tablet, Extended Release, 14-count — NDC 0536-1213-88 (Billing 00536-1213-88)

by Rugby Laboratories · 14 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 14 tablets of Maximum Strength Guaifenesin DM Guaifenesin, Dextromethorphan HBr 60 mg; 1200 mg Tablet, Extended Release from Rugby Laboratories, no longer marketed (first marketed Nov 2018), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $0.5446 per tablet (NADAC). It is this product's only package size.

NDC 00536-1213-88
🏷️ FDA NDC (as labeled) 0536-1213-88 billing pads the labeler segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 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

⚠️
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 Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1213-88
Product NDC 0536-1213
11-digit billing NDC 00536121388
NCPDP billing unit EA — each (per item)
RxCUI 1099074
UNII 9D2RTI9KYH, 495W7451VQ
UPC 0305361213886
Application # ANDA209692
SPL Set ID 2c9515f8-3120-4dbb-a7fc-d89fc5727148
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 Sep 2026)
Marketing start 2018-11-05
Marketing end 2026-09-28
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43997002527475
GPI class Mucus Relief DM Max
GCN Seq No 042105
GCN 93677
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 MAX ER 1200-60 MG
FDB brand name Mucus Relief Dm Max Er
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 042105
  • GCN: 93677
  • GPI-14 (Medi-Span): 43997002527475
  • HICL (First Databank): 000223
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 1099074
Why two NDCs? The FDA registers this code as 0536-1213-88 — a 4-4-2 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 labeler segment → 00536-1213-88. 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.

Clinical

Label name MUCUS RLF DM MAX ER 1200-60 MG Ingredient Guaifenesin/Dextromethorphan
📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin guide →

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 eaPer package
Retail pharmacies payNADAC · weekly $0.545 $7.62 / 14 tablet
Medicaid paysCMS SDUD · 12 mo $0.8379 $11.73 / 14 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.565 $0.510
▲ Up 4% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00536-1213-88 You're viewing this Main listing 14 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2018-11-05 Sep 28, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Guaifenesin DM 60 mg/1; 1200 mgthis 00536-1213-88 Rugby 14 tablets $0.545 — Discontinued —
Rugby Mucus Relief Dm Er 1200 mg/1; 60 mg 00536-1447-88 Rugby 14 tablets $0.545 — Availability likely —
good neighbor pharmacy mucus dm 1200 mg/1; 60 mg 46122-0637-03 Amerisource 28 tablets $0.545 — Availability likely —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 70000-0464-01 Cardinal 28 tablets $0.545 — Availability likely —
Mucus Relief DM 60 mg/1; 1200 mg 70677-1049-01 Strategic 1 tablet $0.545 — Availability likely —
Mucus Relief DM 60 mg/1; 1200 mg 83324-0137-14 QUALITY 1 tablet $0.545 — Availability likely —
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief 60 mg/1; 1200 mg 00031-8765-04 Haleon 4 tablets — — FDA listed —
good sense mucus dm 1200 mg/1; 60 mg 00113-0812-03 L 1 tablet — — FDA listed —
Mucus Relief DM Extended Release Caplets Maximum Strength 60 mg/1; 1200 mg 00363-0437-14 Walgreens 14 tablets — — FDA listed —
Maximum Strength Mucus Relief DM 1200 mg/1; 60 mg 00363-0510-65 WALGREEN 7 tablets — — FDA listed —
mucus relief dm 1200 mg/1; 60 mg 00363-6812-30 Walgreen 28 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 11673-0267-05 Target 14 tablets — — FDA listed —
mucus relief DM MAX 1200 mg/1; 60 mg 11822-1812-00 Rite 14 tablets — — Discontinued —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 11822-7340-04 Rite 42 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide HBR 1200 mg/1; 60 mg 11822-9996-01 RITE-AID 14 tablets — — FDA listed —
Mucus Relief DM MAXIMUM STRENGTH 1200 mg/1; 60 mg 21130-0989-03 Better 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 30142-0275-05 KROGER 7 tablets — — FDA listed —
Guaifenesin And Dextromethorphan Hbr 1200 mg/1; 60 mg 30142-0963-14 Kroger 14 tablets — — FDA listed —
Topcare Mucus DM 1200 mg/1; 60 mg 36800-0592-30 Topco 28 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 37808-0730-42 H 42 tablets — — FDA listed —
mucus relief dm 60 mg/1; 1200 mg 37808-0812-66 H 14 tablets — — Discontinued —
Mucus Relief DM 60 mg/1; 1200 mg 37808-0834-14 H 14 tablets — — FDA listed —
Equaline Mucus DM 1200 mg/1; 60 mg 41163-0781-66 United 14 tablets — — FDA listed —
mucus dm 1200 mg/1; 60 mg 41250-0812-30 Meijer 28 tablets — — Discontinued —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 41415-0999-14 PUBLIX 14 tablets — — FDA listed —
mucus dm 60 mg/1; 1200 mg 42507-0812-66 HyVee 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 1200 mg/1; 60 mg 43598-0115-28 Dr. 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 1200 mg/1; 60 mg 43598-0232-37 Dr. 14 tablets — — FDA listed —
Mucus DM 1200 mg/1; 60 mg 46122-0420-03 Amerisource 7 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 49035-0824-28 EQUATE 28 tablets — — FDA listed —
Maximum Strength Mucus Relief DM 1200 mg/1; 60 mg 49035-0956-61 Wal-Mart 28 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 50090-6020-00 A-S 14 tablets — — FDA listed —
Mucinex DM Maximum Strength 1200 mg/1; 60 mg 50090-6549-00 A-S 14 tablets — — FDA listed —
Good Sense Mucus Dm 1200 mg/1; 60 mg 50090-7258-00 A-S 14 tablets — — FDA listed —
Rugby Mucus Relief Dm Er 1200 mg/1; 60 mg 50090-7891-00 A-S 14 tablets — — FDA listed —
Maximum Strength Cough And Congestion Extended Release 1200 mg/1; 60 mg 51316-0060-65 CVS 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 1200 mg/1; 60 mg 51316-0600-70 CVS 14 tablets — — FDA listed —
Mucus Relief Dm 1200 mg/1; 60 mg 51316-0671-55 CVS 42 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 51660-0110-54 OHM 14 tablets — — FDA listed —
Exchange Select Mucus DM 1200 mg/1; 60 mg 55301-0812-66 Army 14 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 55319-0734-07 Family 1 tablet — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 55319-0741-14 Family 1 tablet — — FDA listed —
DG health mucus dm 1200 mg/1; 60 mg 55910-0575-03 Dolgencorp, 1 tablet — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0715-05 Aurohealth 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0825-06 Aurohealth 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0849-11 Aurohealth 7 tablets — — FDA listed —
Mucus Relief DM 1200 mg/1; 60 mg 60000-0057-65 Ahold 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 63304-0110-54 SUN 14 tablets — — FDA listed —
Mucinex DM Maximum Strength 1200 mg/1; 60 mg 63824-0072-02 Reckitt 1 tablet — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 63868-0870-14 QUALITY 14 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 63941-0734-14 Best 14 tablets — — FDA listed —
kirkland signature mucus dm 60 mg/1; 1200 mg 63981-0812-01 Costco 84 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 65162-0039-03 Amneal 30 tablets — — FDA listed —
Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength 1200 mg/1; 60 mg 67091-0315-14 Winco 7 tablets — — FDA listed —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 67091-0345-14 WinCo 14 tablets — — FDA listed —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 68016-0674-14 Chain 14 tablets — — FDA listed —
members mark mucus relief dm 1200 mg/1; 60 mg 68196-0812-45 Sam's 56 tablets — — FDA listed —
Members Mark Mucus Relief DM 1200 mg/1; 60 mg 68196-0999-56 SAM'S 14 tablets — — FDA listed —
Berkley and Jensen Mucus Relief DM 1200 mg/1; 60 mg 68391-0812-45 BJWC 56 tablets — — FDA listed —
Maximum Strength Mucus DM Extended Release 1200 mg/1; 60 mg 69842-0059-10 CVS 7 tablets — — FDA listed —
mucus dm extended release 1200 mg/1; 60 mg 69842-0812-30 CVS 28 tablets — — Discontinued —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 71179-0011-21 VESPYR 7 tablets — — FDA listed —
Mucus Relief DM 1200 mg/1; 60 mg 72036-0980-65 Harris 7 tablets — — FDA listed —
basic care mucus dm 1200 mg/1; 60 mg 72288-0812-55 Amazon.com 42 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 72476-0734-14 Care 14 tablets — — FDA listed —
Mucus Relief - Dm Maximum Strength 60 mg/1; 1200 mg 73581-0405-98 YYBA 98 tablets — — FDA listed —
Mucus Relief - Dm Maximum Strength 60 mg/1; 1200 mg 73581-0406-01 YYBA 100 tablets — — FDA listed —
Guaifenesin And Dextromethorphan Hbr 1200 mg/1; 60 mg 76162-0032-56 TOPCO 7 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 81522-0734-14 FSA 1 tablet — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 85766-0046-28 Sportpharm 7 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color yellow
ShapeOval
ImprintAN039
Size22 mm
ScoringNot scored
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescarbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerRugby Laboratories
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA209692 (ANDA)
Labeler code00536
First marketedNov 2018
Product typeHuman Otc Drug
Portfolio149 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 57 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 tablet every 12 hours; not more than 2 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).

📦 Storage and Handling 10 words ▾

Other information store between 20º to 25ºC (68º to 77ºF)

🧪 Active Ingredient 13 words ▾

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 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

📄 Do Not Use 61 words ▾

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 29 words ▾

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 10 words ▾

When using this product, do not use more than directed.

📄 Stop Use and Ask a Doctor If 31 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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).

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 112 words ▾

Principal Display Panel Compare to the active ingredients in Maximum Strength Mucinex® DM* Maximum strength Mucus Relief DM Guaifenesin | 1200 mg Expectorant Dextromethorphan HBr | 60 mg Cough Suppressant 12-hour relief Controls Cough Thins & Loosens Mucus Extended Release Tablets *This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex® DM. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com

Package Label RUGBY Maximum Strength Guaifenesin DM Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

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

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 this package alone, 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 – Q1 2026 · 5 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
3K
Units reimbursed last 4 qtrs
71.9K
Gross reimbursed last 4 qtrs
$60.2K
Avg / prescription
$20.23
Avg / unit
$0.8379
Latest quarter Q1 2026
326Rx
Medicaid pays / ea
$0.8379
gross reimbursed
vs
NADAC / ea
$0.5446
acquisition cost
=
Spread
+$0.2933
+54% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 1,223 Rx Managed care · 1,753 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: 1,846 units · 32.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 24,118 units · 123 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: 872 units · 12.7 per 100k residents IN Ohio: 27,279 units · 231 per 100k residents OH Pennsylvania: 442 units · 3.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 711 units · 35.9 per 100k residents NE Missouri: no data reported MO Kentucky: 8,923 units · 197 per 100k residents KY West Virginia: no data reported WV Virginia: 1,033 units · 11.9 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 4,243 units · 57.1 per 100k residents 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: no data reported GA D.C.: no data reported DC Hawaii: 531 units · 37.0 per 100k residents HI Texas: 1,852 units · 6.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.4231
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 Ohio 231 /100k
2 Kentucky 197 /100k
3 New York 123 /100k
4 Arizona 57.1 /100k
5 Hawaii 37.0 /100k
6 Nebraska 35.9 /100k
7 Minnesota 32.2 /100k
8 Indiana 12.7 /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 Guaifenesin, Dextromethorphan HBr — the ingredient across all brands.

Top reported reactions

Covid-1910
Dyspnoea8
Disease Recurrence7
Asthenia6
Cough5
Fatigue5
Pneumonia5

Age at onset

Adolescent1
Adult2
Elderly4

Reporter sex

64 reports
Male · 43%
Female · 57%

Serious outcomes

Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 11 2
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.

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 ✓ Available
Inactive ingredients (structured) ✓ 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 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.
Who lists this product with the FDA?
Rugby Laboratories 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.
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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.