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nitetime cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL Solution, 355 mL — NDC 41250-0811-40 package photo

nitetime cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL Solution, 355 mL

by Meijer Distribution Inc · 355 mL in 1 BOTTLE (41250-811-40)
NDC 41250-0811-40
🏷️ FDA NDC (as labeled) 41250-811-40 billing pads the product segment with a zero
OTC 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 →

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) 41250-811-40
Product NDC 41250-811
11-digit billing NDC 41250081140
RxCUI 1431245
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Application # M012
SPL Set ID 3a33c6ce-aada-4099-8c61-49c86c0fc1a8
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Receptor Antagonists [MoA
Mechanism of action Adrenergic alpha1-Agonists; Histamine Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-23
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 41250-811-40 — 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 → 41250-0811-40. 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 Anilides class.

Drug family (ATC) Anilides
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

LabelerMeijer Distribution Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code41250
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio245 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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Nitetime Cold and Flu is an over-the-counter liquid solution taken by mouth, formulated as an OTC monograph product. It combines acetaminophen, a pain reliever and fever reducer; dextromethorphan, a cough suppressant; doxylamine succinate, a sedating antihistamine meant to promote sleep; and phenylephrine, a decongestant. This combination is typically used to relieve multiple cold and flu symptoms, particularly for nighttime use when symptom relief and rest are desired.

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.

💊 What it looks like

Color Green / Orange
FlavorMenthol
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.

From the label’s inactive-ingredient sectionalcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose anhydrous citric acid, FD&C yellow #6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price systemPer mLPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Severe NightTime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00113-0019-40 L. 354 ml $0.010 — Availability likely —
foster and thrive nighttime severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 70677-1030-01 Strategic 355 ml $0.013 — FDA listed —
Good Sense Severe NightTime Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00113-0763-34 L. 237 ml — — Discontinued —
good sense night time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 00113-2501-40 L. 354 ml — — FDA listed —
Night Time Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0331-26 Walgreen 237 ml — — FDA listed —
severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0623-40 Walgreen 355 ml — — FDA listed —
Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0763-40 Walgreen 355 ml — — FDA listed —
nighttime severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 00363-2029-40 Walgreen 355 ml — — FDA listed —
Walgreen NightTime Cold and Flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-6142-12 WALGREENS 354 ml — — FDA listed —
Nighttime Severe Honey Cold and Flu 6.25 mg/15mL; 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 11673-0322-01 TARGET 354 ml — — FDA listed —
Nighttime severe cold and flu 20 mg/30mL; 650 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11673-0828-01 TARGET 354 ml — — FDA listed —
nighttime severe cold and flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11822-0511-01 Rite 355 ml — — FDA listed —
severe cold and flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11822-0763-01 Rite 355 ml — — FDA listed —
severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 11822-4099-00 Rite 355 ml — — FDA listed —
Signature Care Nighttime Severe Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 21130-0129-40 Safeway 355 ml — — FDA listed —
NightTime Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 30142-0763-40 Kroger 354 ml — — FDA listed —
topcare nite time cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 36800-0291-40 Topco 355 ml — — FDA listed —
Vicks NyQuil Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 37000-0812-01 The 30 ml — — FDA listed —
Vicks NyQuil Severe Cold and Flu 10 mg/30mL; 12.5 mg/30mL; 20 mg/30mL; 650 mg/30mL 37000-0815-08 The 236 ml — — FDA listed —
nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 37808-0763-40 H 355 ml — — FDA listed —
equaline nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41163-0763-40 United 355 ml — — FDA listed —
Severe Cold and Flu Nighttime Honey 10 mg/15mL; 5 mg/15mL; 6.25 mg/15mL; 325 mg/15mL 41226-0767-01 Kroger 354 ml — — FDA listed —
Nighttime Severe Cold and Flu 12.5 mg/30mL; 10 mg/30mL; 650 mg/30mL; 20 mg/30mL 41226-0775-01 Kroger 354 ml — — FDA listed —
Nitetime Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41250-0763-40 Meijer 355 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mLthis 41250-0811-40 Meijer 355 ml — — FDA listed —
CareOne Nighttime Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41520-0561-40 American 355 ml — — FDA listed —
Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 42507-0020-40 HyVee 355 ml — — FDA listed —
Severe Cold and Flu Night time 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 42507-0763-40 HyVee 355 ml — — FDA listed —
severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 42507-0861-40 HyVee 355 ml — — FDA listed —
equate nighttime cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49035-0807-40 Wal-Mart 355 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49580-0416-08 P 237 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49580-4160-08 P 237 ml — — FDA listed —
Tylenol Cold plus Flu plus Cough Night 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 50580-0369-01 Kenvue 240 ml — — FDA listed —
nighttime severe 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 51316-0179-40 CVS 355 ml — — FDA listed —
Severe Cold And Flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 51316-0533-40 CVS 355 ml — — FDA listed —
CVS NightTime Cold 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 51316-0641-12 CVS 354 ml — — FDA listed —
Severe Nighttime Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55319-0641-08 Family 237 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55910-0716-08 Dolgencorp, 237 ml — — FDA listed —
dg health cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55910-0900-34 Dolgencorp, 237 ml — — FDA listed —
DG Health Cold and Flu Severe 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 55910-0928-40 Dolgencorp 355 ml — — FDA listed —
nitetime severe 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 56062-0763-40 Publix 355 ml — — FDA listed —
Rompe Pecho Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 58593-0830-06 EFFICIENT 1 bottle — — FDA listed —
Nighttime SEVERE 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 59640-0423-40 H 355 ml — — FDA listed —
Severe Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 59779-0763-34 CVS 237 ml — — Discontinued —
VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 6.25 mg/15mL 69423-0807-08 Procter 236 ml — — FDA listed —
Vicks NyQuil Severe Honey Cold and Flu 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 6.25 mg/15mL 69423-0968-08 Procter 236 ml — — FDA listed —
NyQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 10 mg/30mL; 12.5 mg/30mL; 20 mg/30mL; 650 mg/30mL 69423-0989-08 The 236 ml — — FDA listed —
Nighttime Severe 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 69842-0800-40 CVS 355 ml — — FDA listed —
basic care nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0189-40 Amazon.com 355 ml — — FDA listed —
basic care nighttime severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 72288-0601-40 Amazon.com 355 ml — — FDA listed —
basic care nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0639-40 Amazon.com 355 ml — — FDA listed —
topcare nite time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 76162-0202-40 Topco 355 ml — — FDA listed —
night time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 79481-8999-00 Meijer, 355 ml — — FDA listed —
equate nighttime cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 79903-0122-12 WALMART 1 bottle — — FDA listed —
Cold and Flu plus Congestion Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 79903-0191-12 WALMART 355 ml — — FDA listed —
Nighttime Severe Cold and Flu 12.5 mg/30mL; 10 mg/30mL; 650 mg/30mL; 20 mg/30mL 85828-0775-01 Grocery 354 ml — — FDA listed —
nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 51316-0415-40 CVS 355 ml — — FDA listed —
Nighttime Severe Cold And Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 51316-0477-40 CVS 355 ml — — FDA listed —
nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0259-40 Amazon.com 355 ml — — FDA listed —
nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0646-40 Amazon.com 355 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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.

🔬 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 Nitetime Cold and Flu (this brand).

Top reported reactions

Contusion1
Dehydration1
Drug Toxicity1
Hepatic Necrosis1
Hepatic Steatosis1
Suspected Suicide1

Reporter sex

2 reports
Male · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
41250-0811-40 You're viewing this 355 mL in 1 BOTTLE (41250-811-40) 2015-07-23 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) — 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

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 41250-811-40, 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: 41250-0811-40, written without dashes as 41250081140. 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 41250-0811-40, the first segment (41250) is the labeler code FDA assigned to Meijer Distribution Inc; the middle segment (0811) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 Meijer Distribution Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meijer Distribution 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 143 words ▾

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 119 words ▾

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~3 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. • if you have ever had an allergic reaction to this product or any of i…

📦 Storage and Handling 41 words ▾

Other information • each 30 mL contains: sodium 44 mg • store at 20-25 ° C (68-77 ° F)

Other information • each 15 mL contains: sodium 15 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate.

🧪 Active Ingredient 42 words ▾

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Active ingredients – (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 64 words ▾

Inactive ingredients alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Inactive ingredients anhydrous citric acid, FD&C yellow #6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

🎯 Purpose 18 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

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