Guaifenesin and Dextromethorphan HBR 1200 mg; 60 mg Tablet, Extended Release
by Dr. Reddy's Laboratories Inc. · 3 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74)
NDC 43598-0115-37
🏷️ FDA NDC (as labeled)
43598-115-37
billing pads the product segment with a zero
This package
Contains14 tablet, extended release in 1 blister pack
Pack sizes7 compare ↓
Also comes in:
7 tablets 43598-0115-28
7 tablets 43598-0115-32
7 tablets 43598-0115-42
7 tablets 43598-0115-70
14 tablets 43598-0115-56
1000 tablets 43598-0115-10
OTC
Generic
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 →
🆔 Identity & classification
FDA NDC (as labeled)
43598-115-37
Product NDC
43598-115
11-digit billing NDC
43598011537
UNII
9D2RTI9KYH, 495W7451VQ
Application #
ANDA217340
SPL Set ID
49d7f70d-ff79-0708-3eda-efa5bf61da6c
Established class (EPC)
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-08-15
Route
ORAL
Dosage form
TABLET, EXTENDED RELEASE
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs?
The FDA registers this code as 43598-115-37 — 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 → 43598-0115-37. 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
LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA217340 (ANDA)
Labeler code43598
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio158 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
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Guaifenesin and Dextromethorphan HBR?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White / Green
ShapeOval
Imprint6
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.
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 system | Per each | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Maximum Strength Guaifenesin DM 60 mg/1; 1200 mg 00536-1213-88 | Rugby | 14 tablets | $0.546 | — | Availability likely | — |
| Rugby Mucus Relief Dm Er 1200 mg/1; 60 mg 00536-1447-88 | Rugby | 14 tablets | $0.546 | — | Availability likely | — |
| good neighbor pharmacy mucus dm 1200 mg/1; 60 mg 46122-0637-03 | Amerisource | 28 tablets | $0.546 | — | Availability likely | — |
| Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 70000-0464-01 | Cardinal | 28 tablets | $0.546 | — | Availability likely | — |
| Mucus Relief DM 60 mg/1; 1200 mg 70677-1049-01 | Strategic | 1 tablet | $0.546 | — | Availability likely | — |
| Mucus Relief DM 60 mg/1; 1200 mg 83324-0137-14 | QUALITY | 1 tablet | $0.546 | — | 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 | — | — | FDA listed | — |
| 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 mgthis 43598-0115-37 | Dr. | 14 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
🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 43598-0115-28 | 4 BLISTER PACK in 1 CARTON (43598-115-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2023-08-15 | Active |
| 43598-0115-32 | 2 BLISTER PACK in 1 CARTON (43598-115-32) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2023-08-15 | Active |
| 43598-0115-37 You're viewing this | 3 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) | 2023-08-15 | Active |
| 43598-0115-42 | 6 BLISTER PACK in 1 CARTON (43598-115-42) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2023-08-15 | Active |
| 43598-0115-70 | 1 BLISTER PACK in 1 CARTON (43598-115-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2023-08-15 | Active |
| 43598-0115-10 | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-115-10) | — | Active |
| 43598-0115-56 | 4 BLISTER PACK in 1 CARTON (43598-115-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) | 2024-05-30 | Active |
Pack size FAQ
What quantity is in NDC 43598-0115-37?
NDC 43598-0115-37 is listed by the FDA — 3 blister pack in 1 carton / 14 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Guaifenesin and Dextromethorphan HBR 1200 mg; 60 mg Tablet, Extended Release?
Bill NDC 43598-0115-37 — the 11-digit billing format is 43598011537. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 | ✓ Available |
| 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
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 43598-115-37, 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: 43598-0115-37, written without dashes as 43598011537. 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 43598-0115-37, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0115) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (37) 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 Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 7 tablets (43598-0115-28), 7 tablets (43598-0115-32), 7 tablets (43598-0115-42). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Dr. Reddy's Laboratories Inc. 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
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 ▾
Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals children under 12 years of age: do not use For 600 mg/30 mg: adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours. For 1200 mg/60 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.
⚠️ Warnings ▾
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 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 ▾
Active ingredients (in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg Guaifenesin USP, 1200 mg Dextromethorphan Hydrobromide USP, 60 mg
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
🎯 Purpose ▾
Purposes Expectorant Cough suppressant
No label section mentions that — try another word, or open the full label on DailyMed below.
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.