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Liquid Acetaminophen 160 mg/5mL Liquid, 473 mL

by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION · 473 mL in 1 BOTTLE (54859-809-16)
NDC 54859-0809-16
🏷️ FDA NDC (as labeled) 54859-809-16 billing pads the product 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

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 54859-809-16
Product NDC 54859-809
11-digit billing NDC 54859080916
NCPDP billing unit ML — per mL (volume)
RxCUI 307675
UNII 362O9ITL9D
Application # M013
SPL Set ID a7dbd4c0-53eb-4368-917b-1432c09ce6b4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN
GPI-14 64200010000912
GPI class Liquid Acetaminophen
GCN Seq No 004484
GCN 16932
HICL code 001866
Ingredient (HICL) Acetaminophen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3E
Therapeutic class — specific (HIC3) Analgesic/Antipyretics,Non-Salicylate
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name ACETAMINOPHEN 160 MG/5 ML LIQ
FDB brand name Acetaminophen
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 54859-809-16 — 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 → 54859-0809-16. 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

LabelerLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio11 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 ACETAMINOPHEN 160 MG/5 ML LIQ Ingredient Acetaminophen
📗 Our plain-language guide HelloPharmacist
  • Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
  • What is acetaminophen actually used for?
  • That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
  • How much is too much? I'm worried about taking it too often.
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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 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 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients:  artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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 $0.011 $5.11 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0447 $21.14 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Oct 2022 Feb 2024 Mar 2026 Aug 2026 $0.014 $0.008
▼ Down 14% over the last 14 months.
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
Children Acetaminophen Oral Solution 160 mg/5mL 00904-7014-16 MAJOR 473 ml $0.011 — Availability likely —
Liquid Acetaminophen 160 mg/5mLthis 54859-0809-16 LLORENS 473 ml $0.011 — Availability likely —
Acetaminophen 160 mg/5mL 57237-0304-12 Rising 118 ml $0.024 — Availability likely +127%
M-Pap 160 mg/5mL 58657-0524-04 Method 120 ml $0.024 — Availability likely +127%
Acetaminophen 160 mg/5mL 69367-0323-04 Westminster 118 ml $0.024 — Availability likely +127%
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 — Availability likely +127%
M-Pap 160 mg/5mL 58657-0525-04 Method 120 ml $0.040 — FDA listed +272%
Acetaminophen 160 mg/5mL 00121-0657-00 PAI 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 00121-1047-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-1314-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-1971-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-2094-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-3141-00 PAI 10 cups — — FDA listed —
Ed Apap 160 mg/5mL 00485-0057-08 EDWARDS 236 ml — — FDA listed —
Acetaminophen 160 mg/5mL 00904-7319-70 Major 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00904-7320-71 Major 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00904-7321-76 Major 10 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0025-01 ATLANTIC 50 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0045-01 ATLANTIC 48 syringes — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0046-01 ATLANTIC 120 syringes — — FDA listed —
MAX relief junior Grape 160 mg/5mL 17856-1122-01 ATLANTIC 50 cups — — FDA listed —
Bactimicina Childrens Pain and Fever 160 mg/5mL 24286-1550-04 DLC 1 bottle — — FDA listed —
Acetaminophen Solution 160 mg/5mL 39328-0031-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 325 mg/10.15mL 39328-0032-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 650 mg/20.3mL 39328-0034-50 Patrin 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 50090-6059-00 A-S 118 ml — — FDA listed —
Acetaminophen 160 mg/5mL 52343-0555-12 Acetris 118 ml — — FDA listed —
DR. SANA PAIN AND FEVER FOR Children 160 mg/5mL 53113-0516-06 GADAL 1 bottle — — FDA listed —
Acetaminophen 650 mg/20.3mL 55154-9449-05 Cardinal 5 cups — — FDA listed —
GeriCare Liquid Pain Relief 160 mg/5mL 57896-0160-16 Geri-Care 473 ml — — FDA listed —
Acetaminophen 650 mg/20.3mL 60687-0740-37 American 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 60687-0751-56 American 10 cups — — FDA listed —
Little Remedies Infant Fever/Pain Reliever 160 mg/5mL 63029-0610-01 Medtech 1 bottle — — FDA listed —
M-Pap 160 mg/5mL 63629-1157-01 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 63629-1158-01 Bryant 473 ml — — FDA listed —
Acetaminophen 160 mg/5mL 71205-0730-04 Proficient 118 ml — — FDA listed —
M-Pap 160 mg/5mL 71335-2755-01 Bryant 118 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-1673-02 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-2404-02 Bryant 473 ml — — FDA listed —
Dr Kids Pain and Fever 160 mg/5mL 73282-2522-01 CalmCo 30 vials — — FDA listed —
Acetaminophen Oral Solution 160 mg/5mL 73564-0816-16 Aldama 1 bottle — — Discontinued —
Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL 82568-0009-04 AARNA 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 83720-0500-04 Oncor 118 ml — — FDA listed —
Children Acetaminophen Oral Solution 160 mg/5mL 83939-0010-01 VERITYRX. 1 ml — — FDA listed —
M-Pap 160 mg/5mL 83939-0011-01 VERITYRX, 5 ml — — FDA listed —
Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 160 mg/5mL 50066-0525-24 Genomma 118 ml — — FDA listed —
Little Remedies Childrens Fever Pain Reliever 160 mg/5mL 63029-0603-02 Medtech 1 bottle — — FDA listed —
Mejoralito Children 160 mg/5mL 69729-0825-04 OPMX 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 68998-0525-24 Marc 118 ml — — FDA listed —
Revasol Acetaminophen Suspension 160 mg/5mL 84379-0311-16 Rnv 474 ml — — FDA listed —
MAX relief junior 160 mg/5mL 71399-0021-04 Akron 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0084-09 Genexa 1 bottle — — FDA listed —
Neo-Lubrina Children 160 mg/5mL 69729-0827-04 OPMX 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0089-09 Genexa 2 bottles — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0041-03 Genexa 5 ml — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 53943-0526-24 Discount 118 ml — — FDA listed —
Dr. Cocoa for Children Pain and Fever 160 mg/5mL 62372-0200-04 Infirst 1 bottle — — FDA listed —
Revasol Acetaminophen Suspension Dye Free 160 mg/5mL 84379-0357-16 Rnv 474 ml — — FDA listed —
Desenfriol-Ito Plus 160 mg/5mL 69729-0815-04 OPMX 1 bottle — — 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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 54859-0809-16, 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
12.3K
Units reimbursed last 4 qtrs
2.5M
Gross reimbursed last 4 qtrs
$112K
Avg / prescription
$9.13
Avg / unit
$0.0447
Latest quarter Q4 2025
2.9KRx
Medicaid pays / mL
$0.0447
gross reimbursed
vs
NADAC / mL
$0.0108
acquisition cost
=
Spread
+$0.0339
+314% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
58% FFS 42% MCO
Fee-for-service · 7,163 Rx Managed care · 5,107 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 40,267 units · 702 per 100k residents MN Wisconsin: 230,021 units · 3,892 per 100k residents WI Michigan: 113,151 units · 1,127 per 100k residents MI New York: 571,435 units · 2,920 per 100k residents NY Vermont: no data reported VT New Hampshire: 3,931 units · 280 per 100k residents NH Oregon: 11,586 units · 274 per 100k residents OR Nevada: 69,017 units · 2,161 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 15,702 units · 125 per 100k residents IL Indiana: 5,822 units · 84.8 per 100k residents IN Ohio: 85,870 units · 729 per 100k residents OH Pennsylvania: 85,550 units · 660 per 100k residents PA New Jersey: 139,558 units · 1,502 per 100k residents NJ Massachusetts: 4,313 units · 61.6 per 100k residents MA California: 606,971 units · 1,558 per 100k residents CA Utah: 28,956 units · 847 per 100k residents UT Colorado: 22,276 units · 379 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 53,316 units · 1,178 per 100k residents KY West Virginia: no data reported WV Virginia: 19,972 units · 229 per 100k residents VA Maryland: 137,976 units · 2,233 per 100k residents MD Connecticut: 18,564 units · 513 per 100k residents CT Rhode Island: 2,577 units · 235 per 100k residents RI Arizona: 129,903 units · 1,748 per 100k residents AZ New Mexico: 30,189 units · 1,428 per 100k residents NM Kansas: 3,346 units · 114 per 100k residents KS Arkansas: 2,180 units · 71.1 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 8,969 units · 167 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 34,669 units · 1,179 per 100k residents MS Alabama: no data reported AL Georgia: 24,950 units · 226 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 2,985 units · 13.2 per 100k residents FL
Units reimbursed · per 100k residents
13.23,892
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 Wisconsin 3,892 /100k
2 New York 2,920 /100k
3 Maryland 2,233 /100k
4 Nevada 2,161 /100k
5 Arizona 1,748 /100k
6 California 1,558 /100k
7 New Jersey 1,502 /100k
8 New Mexico 1,428 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Liquid Acetaminophen (this brand).

Top reported reactions

Fatigue20,901
Pain18,469
Nausea18,167
Headache17,127
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,579

Reporter sex

0 reports

Serious outcomes

Death49,977
Life-threatening21,902
Disabling12,025
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,614 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
54859-0809-16 You're viewing this 473 mL in 1 BOTTLE (54859-809-16) 2019-10-01 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

⏱️ Dosage and Administration 106 words ▾

Directions do not take more than directed find dose in chart below if possible, use weight to dose, otherwise use age dosage may be repeasted every 4 hours, or as directed by a doctor do not give more than 5 doses in 24 hours Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95 over 95 Age (years) under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage Teaspoonful (tsp) consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

⚠️ Warnings 206 words ▾

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday 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.

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. Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warfarin. When using this product: Do not exceed recommended dose. Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present.

These could be signs of a serious condition.

🧪 Active Ingredient 9 words ▾

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

🎯 Purpose 4 words ▾

Purpose Pain Reliever/Fever Reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54859-0808-08 · Llorens 54859-0811-16 · LLORENS →
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.