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Cold and Head Congestion Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 200 mg; 5 mg Tablet, Coated — NDC 68016-717-24 (Billing 68016-0717-24)

by CHAIN DRUG CONSORTIUM · 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK

This is a package of Cold and Head Congestion Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 200 mg; 5 mg Tablet, Coated from CHAIN DRUG CONSORTIUM, no longer marketed (first marketed Jun 2015), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026. It is this product's only package size.

NDC 68016-0717-24
🏷️ FDA NDC (as labeled) 68016-717-24 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-717-24
Product NDC 68016-717
11-digit billing NDC 68016071724
NCPDP billing unit EA — each (per item)
RxCUI 1243679
UNII 362O9ITL9D, 495W7451VQ, 04JA59TNSJ
UPC 0840986032455
Application # M012
SPL Set ID f3163a9f-e916-4b61-80ab-ed5f1e7579f8
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2015-06-01
Marketing end 2026-07-31
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

GCN Seq No 061462
GCN 97253
HICL code 035445
Ingredient (HICL) Phenylephrine/Dm/Acetaminop/Gg
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4P
Therapeutic class — specific (HIC3) Non-Opioid Antituss-Decongestant-Analgesic-Expect
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name PRESSURE-PAIN-COLD CAPLET
FDB brand name Pressure-Pain-Cold
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 061462
  • GCN: 97253
  • HICL (First Databank): 035445
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1243679
Why two NDCs? The FDA registers this code as 68016-717-24 — 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 → 68016-0717-24. 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.

Clinical

Label name PRESSURE-PAIN-COLD CAPLET Ingredient Phenylephrine/Dm/Acetaminop/Gg
🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth that combines three active ingredients commonly used to help manage cold and head congestion symptoms. Acetaminophen is typically used to reduce fever and relieve pain or aches. Phenylephrine hydrochloride functions as a decongestant to help shrink swollen nasal passages and relieve congestion. Guaifenesin is an expectorant typically used to help thin and loosen mucus so it is easier to clear from the airways.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68016-0717-24 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK 2015-06-01 Jul 31, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 46122-0412-62 AmeriSource 12 tablets $0.111 — Availability likely —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 46122-0415-62 AmeriSource 12 tablets $0.111 — Availability likely —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 46122-0712-60 AMERISOURCE 10 tablets $0.111 — Availability likely —
Sinus Relief Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 70000-0080-01 CARDINAL 10 tablets $0.111 — Availability likely —
Head Congestion and Mucus 325 mg/1; 200 mg/1; 5 mg 70000-0083-01 Cardinal 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70677-1005-01 STRATEGIC 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70677-1259-01 Strategic 12 tablets $0.111 — Availability likely —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83324-0107-20 CHAIN 10 tablets $0.111 — Availability likely —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 83324-0112-24 CHAIN 12 tablets $0.111 — Availability likely —
Cold plus Flu Congestion Severe 325 mg/1; 200 mg/1; 5 mg 83324-0114-24 CHAIN 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 83324-0115-24 CHAIN 12 tablets $0.111 — Availability likely —
Mucinex Sinus-Max Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63824-0201-44 Reckitt 2 tablets $0.529 — FDA listed —
Severe Sinus Daytime, Non-Drowsy 325 mg/1; 200 mg/1; 5 mg 00363-5027-07 Walgreen 12 tablets — — Discontinued —
Sinus Pressure and Pain 325 mg/1; 200 mg/1; 5 mg 00363-6028-09 Walgreen 10 tablets — — FDA listed —
Severe Sinus Congestion 325 mg/1; 200 mg/1; 5 mg 00363-6150-09 Walgreen 10 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy/Daytime 325 mg/1; 200 mg/1; 5 mg 11822-0527-08 Rite 12 tablets — — FDA listed —
severe sinus congestion relief Maximum Strength 325 mg/1; 200 mg/1; 5 mg 11822-5160-09 Rite 10 tablets — — FDA listed —
Severe Sinus Congestion and Pain Maximum Strength 325 mg/1; 200 mg/1; 5 mg 21130-0615-09 Better 10 tablets — — FDA listed —
Sinus PE Head Congestion and Mucus 325 mg/1; 200 mg/1; 5 mg 21130-0627-08 Better 12 tablets — — FDA listed —
Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 30142-0727-08 Kroger 12 tablets — — FDA listed —
Daytime Sinus Severe 325 mg/1; 200 mg/1; 5 mg 30142-0732-08 Kroger 12 tablets — — FDA listed —
Sinus Relief Pressure and Pain 325 mg/1; 200 mg/1; 5 mg 30142-0828-09 Kroger 10 tablets — — FDA listed —
Sinus Congestion and Pain Severe 200 mg/1; 5 mg/1; 325 mg 36800-0505-05 TopCare 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 36800-0575-02 TopCo 12 tablets — — FDA listed —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 36800-0793-02 TOPCARE 12 tablets — — FDA listed —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 37808-0273-02 HEB 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 37808-0367-02 HEB 10 tablets — — FDA listed —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 37808-0775-02 HEB 12 tablets — — FDA listed —
Head Congestion Plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 41163-0712-02 United 12 tablets — — FDA listed —
sinus severe 325 mg/1; 200 mg/1; 5 mg 41250-0219-05 Meijer 12 tablets — — Discontinued —
mucus relief sinus severe congestion and pain 325 mg/1; 200 mg/1; 5 mg 41250-0267-02 Meijer 10 tablets — — Discontinued —
Cold Relief Severe Head Congestion 325 mg/1; 200 mg/1; 5 mg 41250-0275-02 Meijer 12 tablets — — Discontinued —
head congestion plus mucus PE 325 mg/1; 200 mg/1; 5 mg 41250-0573-02 MEIJER 12 tablets — — Discontinued —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 42507-0173-02 HYVEE 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 42507-0219-05 HYVEE 12 tablets — — FDA listed —
Cold plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 42507-0375-02 HYVEE 12 tablets — — FDA listed —
Xpect Cold Relief 200 mg/1; 325 mg/1; 5 mg 42961-0112-11 Cintas 160 tablets — — Discontinued —
Severe Congestion Relief Maximum Strength Sinus 325 mg/1; 200 mg/1; 5 mg 49035-0165-09 Wal-Mart 10 tablets — — FDA listed —
Sinus Congestion and Pain Severe 325 mg/1; 200 mg/1; 5 mg 49035-0527-08 Wal-Mart 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50269-0507-25 JC 2 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50269-0551-01 JC 2 tablets — — FDA listed —
SUDAFED PE Head Congestion Plus Mucus 325 mg/1; 200 mg/1; 5 mg 50580-0447-01 Kenvue 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50580-0507-01 Kenvue 12 tablets — — FDA listed —
Tylenol Cold Plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 50580-0566-25 Kenvue 12 tablets — — FDA listed —
Head Congestion Mucus PE 325 mg/1; 200 mg/1; 5 mg 50804-0173-02 GOODSENSE 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50804-0672-05 GoodSense 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 50804-0805-03 GoodSense 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50844-0572-02 L.N.K. 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 51316-0516-09 CVS 10 tablets — — FDA listed —
Severe Sinus Pain and Congestion 325 mg/1; 200 mg/1; 5 mg 51316-0927-08 CVS 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 53209-1004-02 Morning 2 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 53943-0167-02 DISCOUNT 10 tablets — — FDA listed —
Cold Plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 53943-0175-02 DISCOUNT 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 53943-0319-05 DISCOUNT 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 55319-0815-19 Family 8 tablets — — FDA listed —
Sinus Severe Daytime 325 mg/1; 200 mg/1; 5 mg 55910-0529-08 DOLGENCORP, 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 55910-0927-08 DOLGENCORP, 12 tablets — — FDA listed —
Severe Sinus Pain and Congestion Daytime 325 mg/1; 200 mg/1; 5 mg 59779-0275-08 CVS 12 tablets — — FDA listed —
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 63824-0241-10 Reckitt 10 tablets — — FDA listed —
Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength 325 mg/1; 200 mg/1; 5 mg 63824-0243-20 Reckitt 10 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 63868-0071-24 Chain 12 tablets — — FDA listed —
Severe Cold Head Congestion 325 mg/1; 200 mg/1; 5 mg 63868-0081-24 Chain 12 tablets — — Discontinued —
Head Congestion Mucus PE 325 mg/1; 200 mg/1; 5 mg 63868-0103-24 CHAIN 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63868-0722-20 Chain 10 tablets — — FDA listed —
Pressure Pain Mucus PE 325 mg/1; 200 mg/1; 5 mg 63868-0747-24 Chain 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63941-0167-02 VALU 10 tablets — — FDA listed —
Pressure and Pain Plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 63941-0173-02 VALU 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 63941-0275-08 Valu 12 tablets — — FDA listed —
Non-Drowsy Sinus Severe, Circle K 325 mg/1; 200 mg/1; 5 mg 66715-5544-09 Lil' 2 tablets — — FDA listed —
Non-Drowsy Sinus Severe, Circle K 200 mg/1; 5 mg/1; 325 mg 66715-5632-03 Lil' 2 tablets — — FDA listed —
Sinus Relief, Caseys 4good 325 mg/1; 200 mg/1; 5 mg 66715-6332-03 Lil' 6 tablets — — FDA listed —
Tylenol Sinus Severe, Lil Drug Store 325 mg/1; 200 mg/1; 5 mg 66715-6457-07 Lil 2 tablets — — FDA listed —
Tylenol Sinus Severe, CVP HEALTH 325 mg/1; 200 mg/1; 5 mg 66715-6557-02 Lil 2 tablets — — FDA listed —
Daytime Sinus Severe 200 mg/1; 5 mg/1; 325 mg 66715-6744-09 Lil' 2 tablets — — FDA listed —
Tylenol Sinus Severe, TRAVEL BASIX 325 mg/1; 200 mg/1; 5 mg 66715-7857-02 Lil 2 tablets — — FDA listed —
Lil Drug Store Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 66715-9757-02 Lil 2 tablets — — FDA listed —
Cold and Head Congestion Relief Severe 325 mg/1; 200 mg/1; 5 mg 67091-0212-24 WinCo 12 tablets — — FDA listed —
Nasal Decongestant PE and Pain Relief Plus Mucus Relief 325 mg/1; 200 mg/1; 5 mg 67091-0349-24 Winco 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 67414-0507-00 Jones 2 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 67751-0239-01 Navajo 2 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 68016-0504-24 CHAIN 12 tablets — — Discontinued —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 68016-0549-20 CHAIN 10 tablets — — Discontinued —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mgthis 68016-0717-24 CHAIN 12 tablets — — Discontinued —
Severe Cold Head Congestion 325 mg/1; 200 mg/1; 5 mg 68998-0175-02 Marc 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 68998-0219-05 MARC 12 tablets — — FDA listed —
Cold plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 68998-0275-02 MARC 12 tablets — — FDA listed —
Congestion and Headache 325 mg/1; 200 mg/1; 5 mg 69842-0651-01 CVS 10 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 69842-0786-02 CVS 10 tablets — — Discontinued —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70264-0026-02 R 2 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 72036-0119-05 Harris 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 72036-0167-02 HARRIS 10 tablets — — FDA listed —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 72036-0175-02 Harris 12 tablets — — FDA listed —
Sinus Sevre 325 mg/1; 200 mg/1; 5 mg 72476-0119-05 RETAIL 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 72476-0167-02 Retail 10 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 73097-0014-02 Savings 2 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 79481-3572-08 Meijer 12 tablets — — FDA listed —
Pressure, Pain and Mucus 325 mg/1; 200 mg/1; 5 mg 79481-5072-08 Meijer 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 79481-5196-09 Meijer 10 tablets — — FDA listed —
Sinus Severe Non Drowsy, Daytime 325 mg/1; 200 mg/1; 5 mg 79481-7250-08 Meijer 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0029-01 Shield 12 tablets — — Discontinued —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0057-01 Shield 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0107-01 Shield 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0121-06 Shield 60 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 85237-1955-01 Select 2 tablets — — 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
Jun 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.

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.

Manufacturer & labeler

LabelerCHAIN DRUG CONSORTIUM
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedJun 2015
Product typeHuman Otc Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

Uses for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

⏱️ Dosage and Administration 50 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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, perists 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 trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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.

📦 Storage and Handling 16 words ▾

Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information

🧪 Active Ingredient 22 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

🎯 Purpose 22 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

📄 Do Not Use 95 words ▾

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 48 words ▾

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 10 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-844-705-4384

📄 Package Label / Principal Display Panel 61 words ▾

PRINCIPAL DISPLAY PANEL Premier Value® COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® COLD + HEAD CONGESTION SEVERE† FOR ADULTS Cold & Head CONGESTION SEVERE Acetaminophen, Phenylephrine HCl, Guaifenesin Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant Relieves: • Headache & Body Aches • Nasal Congestion • Fever & Sore Throat • Mucus & Chest Congestion ACTUAL SIZE 24 COOL TASTE CAPLETS image description

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

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 Cold and Head Congestion Severe (this brand).

Top reported reactions

Cardio-respiratory Arrest1
Completed Suicide1
Death1
Kidney Infection1
Product Barcode Issue1

Reporter sex

3 reports
Male · 67%
Female · 33%

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2023 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
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

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
CHAIN DRUG CONSORTIUM 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.
← 68016-0715-01 · Chain 68016-0731-04 · Chain →
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.