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GUAIFENESIN 200 mg/10mL Solution — NDC 00121-1488-00 package photo

GUAIFENESIN 200 mg/10mL Solution

by PAI Holdings, LLC dba PAI Pharma · 10 TRAY in 1 CASE (0121-1488-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1488-10)
NDC 00121-1488-00
🏷️ FDA NDC (as labeled) 0121-1488-00 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0121-1488-00
Product NDC 0121-1488
11-digit billing NDC 00121148800
NCPDP billing unit ML — per mL (volume)
RxCUI 310604
UNII 495W7451VQ
Application # M012
SPL Set ID c2e53fb5-2798-47c8-9285-d1077d46e629
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-09-01
Route ORAL
Dosage form SOLUTION
Substance GUAIFENESIN
GPI-14 43200010000910
GPI class guaiFENesin
GCN Seq No 022210
GCN 02512
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 GUAIFENESIN 200 MG/10 ML CUP
FDB brand name Guaifenesin
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0121-1488-00 — 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 → 00121-1488-00. 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.

🏭 Manufacturer & labeler

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedSep 2002
Product typeHuman Otc Drug
Portfolio142 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 GUAIFENESIN 200 MG/10 ML CUP Ingredient Guaifenesin
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin is what's called an expectorant — it works to thin and loosen the mucus sitting in your chest and airways. That makes it easier to cough the mucus up and out, so instea...
  • What exactly does guaifenesin do for my cough?
  • Guaifenesin is meant for short-term use. If your cough isn't getting better after 7 days, keeps coming back, or shows up alongside a fever, rash, or a headache that won't go away,...
  • How long can I take it before I should call my doctor?
📖 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.

💊 What it looks like

Color red
FlavorRaspberry
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesAcesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0779 $77.90 / 1000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
Chest Congestion Relief 100 mg/5mL 00536-1314-85 RUGBY 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 58657-0508-16 Method 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 83720-0503-16 Oncor 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 58657-0509-16 Method 473 ml $0.013 — FDA listed —
Good Neighbor Adult Tussin Mucus and chest congestion 200 mg/10mL 46122-0785-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Tusnel EX 100 mg/5mL 54859-0507-04 Llorens 118 ml $0.023 — Availability likely —
Mucolyte 100 mg/5mL 57237-0359-12 Rising 118 ml $0.023 — Availability likely —
Tussin 200 mg/10mL 70677-1186-01 Strategic 1 bottle $0.023 — Availability likely —
Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 82568-0012-04 AARNA 1 bottle $0.023 — Availability likely —
QCH Adult Tussin 541 200 mg/10mL 83324-0024-04 Chain 1 bottle $0.023 — Availability likely —
Rugby Mucus and Chest Congestion 541 200 mg/10mL 00536-1430-97 Rugby 1 bottle $0.023 — Availability likely —
Leader Adult Tussin Mucus and Chest Congestion 541 200 mg/10mL 70000-0696-01 CARDINAL 1 bottle $0.023 — Availability likely —
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor 400 mg/20mL 63824-0537-66 Reckitt 180 ml $0.061 — FDA listed —
Guaifenesin 100 mg/5mL 00121-0744-04 PAI 118 ml — — FDA listed —
Guaifenesin 200 mg/10mLthis 00121-1488-00 PAI 10 cups — — FDA listed —
Guaifenesin 100 mg/5mL 00121-1744-00 PAI 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 00121-2232-00 PAI 10 cups — — FDA listed —
Walgreen Cherry 200 mg/10mL 00363-7043-08 WALGREEN 1 bottle — — FDA listed —
Childrens Chest Congestion Relief 100 mg/5mL 00363-7504-04 WALGREENS 1 bottle — — FDA listed —
Tusnel EX 100 mg/5mL 50090-6542-00 A-S 118 ml — — FDA listed —
CVS Adult Mucus plus Chest Congestion 200 mg/10mL 51316-0437-08 CVS 1 bottle — — FDA listed —
CVS Adult Mucus chest congestion 200 mg/10mL 51316-0743-08 CVS 1 bottle — — FDA listed —
Tussin 100 mg/5mL 53943-0507-26 Discount 237 ml — — FDA listed —
Childrens Chest Congestion Relief Grape 100 mg/5mL 53943-0511-24 Discount 118 ml — — FDA listed —
Llorens Care Tussin 100 mg/5mL 54859-0510-16 Llorens 473 ml — — FDA listed —
Guaifenesin 200 mg/10mL 55154-5780-05 Cardinal 5 cups — — FDA listed —
Guaifenesin 100 mg/5mL 55154-9450-05 Cardinal 5 cups — — FDA listed —
Geri-Tussin 200 mg/10mL 57896-0293-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin 100 mg/5mL 57896-0693-16 Geri-Care 473 ml — — FDA listed —
Cough Out 100 mg/5mL 58593-0255-04 Efficient 118 ml — — Discontinued —
Rompe Pecho SF 100 mg/5mL 58593-0265-04 Efficient 118 ml — — Discontinued —
Rompe Pecho EX 200 mg/10mL 58593-0829-04 Efficient 118 ml — — FDA listed —
Guaifenesin 100 mg/5mL 60687-0852-17 American 10 cups — — FDA listed —
Guaifenesin 200 mg/10mL 60687-0863-56 American 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 60687-0874-16 American 10 cups — — FDA listed —
Childrens Mucus Relief Chest Congestion 100 mg/5mL 63868-0770-04 Chain 1 bottle — — FDA listed —
SDA Laboratories Tussin 100 mg/5mL 66424-0563-16 SDA 473 ml — — FDA listed —
DRx Choice Fruit Punch 200 mg/10mL 68163-0743-04 Raritan 1 bottle — — FDA listed —
Adult Tussin 200 mg/10mL 69230-0332-23 Camber 1 bottle — — FDA listed —
Reliable-1 Tussin 100 mg/5mL 69618-0068-54 RELIABLE 118 ml — — FDA listed —
Akin 100 mg/5mL 69822-0200-02 Southern 118 ml — — FDA listed —
MAX Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 71399-0024-04 Akron 1 bottle — — FDA listed —
MAX Tussin Mucus and Chest Congestion 200 mg/10mL 71399-0054-08 Akron 1 bottle — — FDA listed —
Guaifenesin STRAWBERRY-BANANA FLAVOR 100 mg/5mL 71800-0059-19 Innovida 119 ml — — FDA listed —
Guaifenesin 100 mg/5mL 72162-2278-02 Bryant 473 ml — — FDA listed —
Guaifed 200 mg/10mL 73564-0801-04 Aldama 118 ml — — FDA listed —
Tussin Expectorant 100 mg/5mL 76281-0507-24 AptaPharma, 118 ml — — FDA listed —
Meijer Adult Mucus Plus chest congestion 200 mg/10mL 79481-7430-08 MEIJER 1 bottle — — FDA listed —
Guaifenesin 100 mg/5mL 81033-0102-51 KESIN 50 cups — — FDA listed —
Quality Choice Adult Tussin Expectorant 200 mg/10mL 83324-0332-04 QUALITY 1 bottle — — FDA listed —
Curewell Tussin 100 mg/5mL 85111-0693-16 RMT 473 ml — — FDA listed —
Revasol Tussin 200 mg/10mL 84379-0313-04 Rnv 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2002
On the market since
Sep 2002
📍
2026
Currently FDA-listed
24 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

🗺️ 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 00121-1488-00, 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
540
Units reimbursed last 4 qtrs
54.9K
Gross reimbursed last 4 qtrs
$4.3K
Avg / prescription
$7.91
Avg / unit
$0.0779
Latest quarter Q4 2025
74Rx
Fee-for-service vs managed care ⓘ
32% FFS 68% MCO
Fee-for-service · 175 Rx Managed care · 365 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,460 units · 44.3 per 100k residents 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: 1,201 units · 12.0 per 100k residents MI New York: 14,369 units · 73.4 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: 628 units · 9.2 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 30,490 units · 328 per 100k residents NJ Massachusetts: 11 units · 0.2 per 100k residents MA California: 684 units · 1.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,295 units · 50.7 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported 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: 1,714 units · 58.3 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.2328
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 Jersey 328 /100k
2 New York 73.4 /100k
3 Mississippi 58.3 /100k
4 Kentucky 50.7 /100k
5 Washington 44.3 /100k
6 Michigan 12.0 /100k
7 Indiana 9.2 /100k
8 California 1.8 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00121-1488-00 You're viewing this 10 TRAY in 1 CASE (0121-1488-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1488-10) 2002-09-01 Active

🧭 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) ✓ 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) ✓ 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0121-1488-00, 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: 00121-1488-00, written without dashes as 00121148800. 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 00121-1488-00, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC dba PAI Pharma; the middle segment (1488) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

USES Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

⏱️ Dosage and Administration 88 words ▾

DIRECTIONS Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician

⚠️ Warnings 104 words ▾

WARNINGS Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients. 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.

📦 How Supplied / Storage and Handling 128 words ▾

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04: 4 fl oz (120 mL) bottle NDC 0121-0744-08: 8 fl oz (237 mL) bottle NDC 0121-0744-16: 16 fl oz (473 mL) bottle NDC 0121-1744-05: 5 mL unit dose cup NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1488-10: 10 mL unit dose cup NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2232-15: 15 mL unit dose cup NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

📦 Storage and Handling 16 words ▾

STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

🧪 Active Ingredient 10 words ▾

DESCRIPTION Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg

🧪 Inactive Ingredients 28 words ▾

Inactive Ingredients Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL

🎯 Purpose 6 words ▾

Expectorant SUGAR FREE / ALCOHOL FREE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-1350-00 · PAI 00121-1544-40 · PAI →
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.