Home › NDC Lookup › Ingredients › Guaifenesin › 63824-0023-07
Mucinex Maximum Strength Guaifenesin 1200 mg Tablet, Extended Release, 7-count — NDC 63824-0023-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mucinex Maximum Strength Guaifenesin 1200 mg Tablet, Extended Release, 7-count — NDC 63824-023-07 (Billing 63824-0023-07)

by Reckitt Benckiser LLC · 1 BLISTER PACK in 1 CARTON / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of 7 tablets of Mucinex Maximum Strength Guaifenesin 1200 mg Tablet, Extended Release from Reckitt Benckiser LLC, marketed since Jun 2012 and currently FDA-listed; retail pharmacies pay about $0.8195 per tablet (NADAC). It is the main listing for this product, which comes in 7 package sizes.

NDC 63824-0023-07
🏷️ FDA NDC (as labeled) 63824-023-07 billing pads the product segment with a zero
This package
Contains7-count Cost per ea$0.8195 NADAC Per package$5.74 / 7 tablets Pack sizes7 compare ↓
Main listing for product 63824-023 · Also comes in: 1 tablet 63824-023-02 12 tablets 63824-023-48 14 tablets 63824-023-35 14 tablets 63824-023-36 14 tablets 63824-023-46 14 tablets 63824-023-56
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 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

NDC database record

One package, one record: these facts belong to NDC 63824-023-07 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63824 labeler · 023 product · 07 package
Package marketed since
Jun 11, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
7 EA per package
Barcode (UPC)
0363824023144
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63824-023-07
Product NDC 63824-023
11-digit billing NDC 63824002307
NCPDP billing unit EA — each (per item)
RxCUI 310621, 891297
UNII 495W7451VQ
UPC 0363824023144
Application # NDA021282
SPL Set ID 47f5323c-ee3a-400d-b133-31d9c286fafd
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-26
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN

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

GPI-14 43200010007450
GPI class Mucinex Maximum Strength
GCN Seq No 063103
GCN 98863
HICL code 000271
Ingredient (HICL) Guaifenesin
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 B3J
Therapeutic class — specific (HIC3) Expectorants
AHFS code 48:16.00.00
AHFS class Expectorants
FDB label name MUCINEX ER 1,200 MG TABLET
FDB brand name Mucinex
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 063103
  • GCN: 98863
  • GPI-14 (Medi-Span): 43200010007450
  • HICL (First Databank): 000271
  • AHFS class code: 48:16.00.00
  • RxCUI (RxNorm): 310621
Why two NDCs? The FDA registers this code as 63824-023-07 — 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 → 63824-0023-07. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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 MUCINEX ER 1,200 MG TABLET Ingredient Guaifenesin
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin doesn't suppress your cough — it actually makes it work better. It loosens and thins the mucus in your chest so your cough can move it out of your airways more effectiv...
  • What exactly does guaifenesin do — does it actually stop my cough?
  • No — extended-release tablets like 12 Hour Mucus Relief and 365 Whole Foods Market Guaifenesin must be swallowed whole. Crushing, chewing, or breaking them releases the medicine al...
  • Can I crush or split the extended-release tablet to make it easier to swallow?
📖 Read our full 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.

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 $0.820 $5.74 / 7 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 $0.820 $0.820
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 Per unit Per pack Marketing startMarketing endStatus
63824-0023-02 63824-023-02 1 POUCH in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 POUCH — — 2021-07-01 — Active
63824-0023-07 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8195 / ea $5.74 2015-06-11 — Active
63824-0023-35 63824-023-35 1 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8195 / ea $11.47 2012-06-26 — Active
63824-0023-36 63824-023-36 2 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8195 / ea $22.95 2012-06-26 — Active
63824-0023-46 63824-023-46 3 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8195 / ea $34.42 2012-06-26 — Active
63824-0023-48 63824-023-48 4 BLISTER PACK in 1 CARTON / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK — — 2012-06-26 — Active
63824-0023-56 63824-023-56 4 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.8195 / ea $45.89 2021-07-01 — Active

This pack has the lowest per-ea cost of the 5 priced pack sizes ($0.8195 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 7-count package — 1 blister pack in 1 carton / 7 tablet, extended release in 1 blister pack.
How does this package differ from NDC 63824-0023-02?
Both are Mucinex Maximum Strength Guaifenesin 1200 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 7-count one, while NDC 63824-0023-02 is the 1 tablet package.
What NDC number is used to bill for this package of Mucinex Maximum Strength Guaifenesin 1200 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucus Relief ER 1200 mg 00536-1249-71 Rugby 14 tablets $0.432 — Availability likely save 47%
Rugby Mucus Relief ER 1200 mg 00536-1451-88 Rugby 7 tablets $0.432 — Availability likely save 47%
good neighbor pharmacy mucus er 1200 mg 46122-0683-74 Amerisource 1 tablet $0.432 — Discontinued save 47%
Good Neighbor Pharmacy Mucus ER 1200 mg 46122-0814-04 Amerisource 7 tablets $0.432 — Availability likely save 47%
Leader Mucus Relief 1200 mg 70000-0721-01 Cardinal 7 tablets $0.432 — Availability likely save 47%
Mucus Relief 1200 mg 70000-0730-01 LEADER/ 14 tablets $0.432 — Availability likely save 47%
Mucus Relief 1200 mg 70677-1051-01 Strategic 1 tablet $0.432 — Availability likely save 47%
Guaifenesin 1200 mg 70677-1258-01 Strategic 14 tablets $0.432 — Availability likely save 47%
Mucus Relief 1200 mg 83324-0096-14 CHAIN 14 tablets $0.432 — Availability likely save 47%
Mucus Relief Extended Release Maximum Strength 1200 mg 70000-0479-01 CARDINAL 14 tablets $0.469 — FDA listed save 43%
Mucinex Maximum Strength 1200 mgthis 63824-0023-07 Reckitt 7 tablets $0.819 — FDA listed —
Good Sense Mucus ER 1200 mg 00113-3650-00 L. 14 tablets — — FDA listed —
Good Sense Mucus ER 1200 mg 00113-4077-01 L. 7 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0033-01 WALGREEN 14 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0570-27 Walgreens 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 00363-0832-14 Walgreens 14 tablets — — FDA listed —
Mucus Relief 1200 mg 00536-1392-88 Rugby 1 tablet — — FDA listed —
Mucus Relief Extended Release 1200 mg 11673-0732-14 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11673-0840-27 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11822-4260-01 RITE 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 21130-0399-01 Better 14 tablets — — FDA listed —
Guaifenesin 1200 mg 21130-0554-27 Safeway, 14 tablets — — FDA listed —
Guaifenesin 1200 mg 25000-0041-12 MARKSANS 500 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 30142-0962-14 Kroger 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 36800-0932-14 TOP 14 tablets — — Discontinued —
Mucus Relief Extended Release Maximum Strength 1200 mg 37808-0762-14 H 14 tablets — — FDA listed —
Mucus Relief 1200 mg 37835-0412-28 Bi-Mart 28 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 41226-0724-89 KROGER 14 tablets — — FDA listed —
mucus relief 1200 mg 41250-0654-02 Meijer 14 tablets — — Discontinued —
Guaifenesin Extended Release 1200 mg 41415-0997-14 PUBLIX 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 41520-0732-14 Care 14 tablets — — FDA listed —
mucus er 1200 mg 42507-0471-14 HyVee 7 tablets — — FDA listed —
Guaifenesin 1200 mg 43598-0009-25 Dr. 14 tablets — — FDA listed —
Guaifenesin 1200 mg 43598-0108-37 Dr. 14 tablets — — FDA listed —
Equate Mucus Relief 1200 mg 49035-0284-48 Wal-Mart 48 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 49483-0724-70 TIME 70 tablets — — FDA listed —
Mucinex Maximum Strength 1200 mg 50090-2301-00 A-S 7 tablets — — Discontinued —
mucus extended release 1200 mg 51316-0400-55 CVS 7 tablets — — FDA listed —
Mucus And Chest Congestion 1200 mg 51316-0520-74 CVS 7 tablets — — FDA listed —
Mucus Relief 1200 mg 51316-0724-94 CVS 14 tablets — — FDA listed —
mucus relief 1200 mg 51316-0728-74 CVS 7 tablets — — FDA listed —
Guaifenesin 1200 mg 51660-0567-54 Ohm 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53041-0191-48 Guardian 7 tablets — — FDA listed —
Guaifenesin Extended-Release 1200 mg 53041-0234-37 Guardian 7 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53942-0204-02 Demoulas 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 53943-0234-07 Discount 14 tablets — — FDA listed —
Mucus Relief 1200 mg 55319-0551-07 Family 1 tablet — — FDA listed —
Mucus Relief 1200 mg 55319-0733-14 Family 1 tablet — — FDA listed —
dg health mucus er max 1200 mg 55910-0626-74 Dolgencorp 14 tablets — — FDA listed —
DG health mucus er max 1200 mg 55910-0887-74 Dolgencorp 7 tablets — — FDA listed —
Crcle Guaifensin Extended Release Tablet, 1200 mg 57483-0280-02 Innovus 56 tablets — — FDA listed —
Giltuss EX Maximum Strength Expectorant 1200 mg 58552-0341-07 Gil 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0811-01 Aurohealth 14 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0865-03 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 59726-0237-07 P 1 tablet — — FDA listed —
Mucus Relief 1200 mg 61504-0204-02 AMERIFOODS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0569-93 Granules 2000 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0840-71 Granules 10 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 63868-0148-14 CHAIN 7 tablets — — FDA listed —
Guaifenesin 1200 mg 65162-0037-03 Amneal 30 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 67091-0404-02 WINCO 7 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 68196-0033-56 SAM'S 14 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0405-14 SAM'S 56 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0960-56 Sam's 14 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 68196-0996-56 SAM'S 14 tablets — — FDA listed —
berkley and jensen mucus relief 1200 mg 68391-0000-45 BJWC 14 tablets — — FDA listed —
Mucus Relief 1200 mg 68391-0724-95 BJWC 84 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 69168-0460-32 Allegiant 100 tablets — — FDA listed —
Guaifenesin 1200 mg 69842-0335-16 CVS 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 69842-0732-14 CVS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 69848-0018-16 GRANULES 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71309-0461-56 Safrel 56 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 72036-0204-02 HARRIS 14 tablets — — FDA listed —
Mucus Relief 1200 mg 72090-0012-01 Pioneer 100 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0613-55 Amazon.com 7 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0650-02 Amazon.com 14 tablets — — FDA listed —
Curist Mucus Relief Maximum Strength 1200 mg 72559-0013-11 Little 14 tablets — — FDA listed —
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg 73581-0402-01 YYBA 100 tablets — — FDA listed —
Guaifenesin 1200 mg 76162-0031-56 TOPCO 14 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0409-01 Topco 7 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0523-01 Topco 14 tablets — — FDA listed —
Mucus Relief 1200 mg 79481-1204-01 Meijer 14 tablets — — FDA listed —
equate mucus relief 1200 mg 79903-0327-14 WALMART 7 tablets — — FDA listed —
Betr chest congestion relief 1200 mg 80267-0002-74 Live 14 tablets — — FDA listed —
Betr remedies chest congestion relief 1200 mg 80267-0010-74 Live 1 tablet — — FDA listed —
Guaifenesin 1200 mg 80513-0413-11 Advanced 110 tablets — — FDA listed —
Expectorant Guaifenesin Extended-Release 1200 mg 81179-0007-04 YET 70 tablets — — FDA listed —
Mucus Relief 1200 mg 81522-0204-02 FSA 14 tablets — — FDA listed —
Up And Up Mucus Relief 1200 mg 82442-0503-01 Target 7 tablets — — FDA listed —
Guaifenesin - Odaat 1200 Mg 83139-0175-01 LODAAT 100 tablets — — FDA listed —
Mucus Relief 1200 mg 84324-0034-01 NUVICARE 24 tablets — — FDA listed —
Dr Simi Mucus Relief Expectorant 1200 mg 85786-0301-14 Farmacias 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71179-0002-21 VESPYR 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0857-93 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 73581-0403-01 YYBA 100 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 70677-1320-01 Strategic 14 tablets — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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
Jun 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 white
ShapeOval
ImprintMucinex;1200
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.

🧪 Avoiding an ingredient? See Guaifenesin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 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.

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

The official label also statescarbomer homopolymer type B; FD&C blue no. 1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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

LabelerReckitt Benckiser LLC
Application holderRECKITT BENCKISER LLC
FDA applicationNDA021282 (NDA)
Labeler code63824
First marketedJun 2012
Product typeHuman Otc Drug
Portfolio174 products on file

More NDCs from Reckitt Benckiser LLC labeler code 63824

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 📄 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 22 words ▾

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

⏱️ Dosage and Administration 61 words ▾

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 102 words ▾

Warnings Do not use for children under 12 years of age 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) 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.

📦 Storage and Handling 6 words ▾

Other information store at 20-25°C (68-77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients carbomer homopolymer type B; FD&C blue no. 1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

🎯 Purpose 2 words ▾

Purpose Expectorant

📄 Do Not Use 10 words ▾

Do not use for children under 12 years of age

📄 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)

📄 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 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 3 words ▾

Questions? 1-866-MUCINEX (1-866-682-4639)

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton NDC 63824-023-35 MAXIMUM STRENGTH Mucinex® 1200 mg guaifenesin extended-release tablets EXPECTORANT 12 HOUR ® Relieves Chest Congestion Thins and Loosens Mucus Immediate and Extended Release EXTENDED-RELEASE TABLETS full carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63824-0019-22 · Reckitt 63824-0041-12 · Reckitt →
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.