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Childrens Pain Relief and Fever Reducer Oral Suspension Cherry ACETAMINOPHEN 160 mg/5mL Suspension — NDC 83474-0001-04 package photo

Childrens Pain Relief and Fever Reducer Oral Suspension Cherry ACETAMINOPHEN 160 mg/5mL Suspension

by Puro Pharma Inc. · 1 BOTTLE in 1 CARTON (83474-001-04) / 118 mL in 1 BOTTLE
NDC 83474-0001-04
🏷️ FDA NDC (as labeled) 83474-001-04 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) 83474-001-04
Product NDC 83474-001
11-digit billing NDC 83474000104
NCPDP billing unit ML — per mL (volume)
RxCUI 307668
UNII 362O9ITL9D
Application # M013
SPL Set ID a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-28
Route ORAL
Dosage form SUSPENSION
Substance ACETAMINOPHEN
GPI-14 64200010001840
GCN Seq No 016947
GCN 26911
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 CHILD PAIN-FEVER 160 MG/5 ML
FDB brand name Children's Pain-Fever
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 83474-001-04 — 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 → 83474-0001-04. 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

LabelerPuro Pharma Inc.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code83474
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio3 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 CHILD PAIN-FEVER 160 MG/5 ML Ingredient Acetaminophen
📖 What it is MedlinePlus · NLM

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 ↗
📗 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.

💊 What it looks like

Color red
FlavorCherry
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 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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the 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 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 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredients   anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

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 $0.021 $2.53 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0336 $3.96 / 118 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
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.022 $0.021
▲ Up 2% over the last 9 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
Pain Reliever Childrens 160 mg/5mL 62011-0460-01 Strategic 1 bottle $0.019 — FDA listed save 12%
Pain and Fever Childrens 160 mg/5mL 62011-0461-01 Strategic 1 bottle $0.019 — FDA listed save 12%
leader childrens pain and fever 160 mg/5mL 70000-0496-01 Cardinal 1 bottle $0.019 — FDA listed save 12%
Childrens Pain Relief 160 mg/5mL 63868-0174-18 QUALITY 118 ml $0.021 — FDA listed save 2%
Pain Relief Childrens 160 mg/5mL 63868-0175-26 QUALITY 1 bottle $0.021 — FDA listed save 2%
good sense childrens pain and fever 160 mg/5mL 00113-0020-26 L. 1 bottle $0.021 — Availability likely —
Good Sense Childrens Pain and Fever 160 mg/5mL 00113-0212-26 L. 1 bottle $0.021 — Availability likely —
good sense childrens pain and fever 160 mg/5mL 00113-0608-26 L. 1 bottle $0.021 — Availability likely —
Good Sense Pain and Fever 160 mg/5mL 00113-8959-26 L. 1 bottle $0.021 — Availability likely —
Rugby Childrens Acetaminophen 160 mg/5mL 00536-1321-97 Rugby 1 bottle $0.021 — Availability likely —
childrens acetaminophen 160 mg/5mL 00904-7445-20 Major 1 bottle $0.021 — Availability likely —
Childrens Acetaminophen 160 mg/5mL 45802-0201-26 Padagis 1 bottle $0.021 — Availability likely —
Good Neighbor Pharmacy Childrens Pain and Fever 160 mg/5mL 46122-0209-26 Amerisource 1 bottle $0.021 — Availability likely —
Good Neighbor Pharmacy childrens pain and fever 160 mg/5mL 46122-0211-26 Amerisource 1 bottle $0.021 — Availability likely —
good neighbor pharmacy pain and fever childrens 160 mg/5mL 46122-0322-26 Amerisource 1 bottle $0.021 — Availability likely —
leader childrens pain and fever 160 mg/5mL 70000-0028-01 Cardinal 1 bottle $0.021 — Availability likely —
leader childrens pain and fever 160 mg/5mL 70000-0481-01 Cardinal 1 bottle $0.021 — Availability likely —
foster and thrive childrens pain and fever 160 mg/5mL 70677-1142-01 Strategic 1 bottle $0.021 — Availability likely —
foster and thrive childrens pain and fever 160 mg/5mL 70677-1143-01 Strategic 1 bottle $0.021 — Availability likely —
Childrens Acetaminophen 160 mg/5mL 72888-0459-01 Advagen 1 bottle $0.021 — Availability likely —
Childrens Acetaminophen 160 mg/5mL 82568-0011-04 AARNA 1 bottle $0.021 — Availability likely —
Pain Relief 160 mg/5mL 83324-0034-04 QUALITY 1 bottle $0.021 — Availability likely —
Pain Reliever 160 mg/5mL 83324-0161-04 QUALITY 1 bottle $0.021 — Availability likely —
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mLthis 83474-0001-04 Puro 1 bottle $0.021 — Availability likely —
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 — Availability likely +14%
good neighbor pharmacy infants pain and fever 160 mg/5mL 46122-0764-34 Amerisource 1 bottle $0.039 — Availability likely +83%
Good Neighbor Pharmacy Infants Pain and Fever 160 mg/5mL 46122-0765-34 Amerisource 1 bottle $0.039 — Availability likely +83%
foster and thrive infants pain and fever 160 mg/5mL 70677-1253-01 Strategic 1 bottle $0.039 — Availability likely +83%
rugby infants acetaminophen 160 mg/5mL 00536-1426-77 Rugby 1 bottle $0.058 — Availability likely +169%
leader infants pain and fever 160 mg/5mL 70000-0674-01 Cardinal 1 bottle $0.058 — Availability likely +169%
Infants Pain Reliever 160 mg/5mL 70677-0117-01 Strategic 1 bottle $0.062 — FDA listed +190%
Good Sense pain and fever 160 mg/5mL 00113-0161-10 L. 1 bottle $0.084 — Availability likely +292%
good sense pain and fever infants 160 mg/5mL 00113-0946-10 L. 1 bottle $0.084 — Availability likely +292%
Acetaminophen 160 mg/5mL 00121-0941-00 PAI 10 cups — — FDA listed —
Dye Free Childrens Acetaminophen 160 mg/5mL 00121-0966-00 PAI 10 cups — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 00121-1781-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-1882-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-2823-94 PAI 10 cups — — FDA listed —
childrens pain and fever 160 mg/5mL 00363-0212-26 Walgreen 1 bottle — — FDA listed —
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0283-04 Walgreens 1 bottle — — FDA listed —
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0285-04 Walgreens 1 bottle — — FDA listed —
Childrens Pain and Fever Cherry flavor 160 mg/5mL 00363-0322-24 Walgreen 1 bottle — — FDA listed —
Childrens Pain and Fever, Grape flavor 160 mg/5mL 00363-0323-24 Walgreen 1 bottle — — FDA listed —
childrens pain and fever 160 mg/5mL 00363-1239-26 Walgreen 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-1630-94 Walgreen 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-6002-02 WALGREEN 1 bottle — — FDA listed —
Dye FreeInfants Pain and Fever 160 mg/5mL 00363-6020-02 WALGREEN 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 00363-6555-04 WALGREENS 1 bottle — — FDA listed —
WalgreenChildrens Pain Fever 160 mg/5mL 00363-6950-04 WALGREENS 1 bottle — — FDA listed —
Walgreen Childrens Pain plus Fever 160 mg/5mL 00363-6958-08 WALGREENS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 00363-7014-05 WALGREENS 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 00363-7015-04 WALGREENS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 00363-8079-36 Walgreen 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 00904-7278-70 Major 10 cups — — FDA listed —
Up and Up childrens acetaminophen 160 mg/5mL 11673-0105-26 Target 1 bottle — — FDA listed —
Up and Up Childrens acetaminophen 160 mg/5mL 11673-0130-26 Target 1 bottle — — FDA listed —
up and up acetaminophen infants 160 mg/5mL 11673-0133-16 Target 1 bottle — — FDA listed —
up and up infants acetaminophen 160 mg/5mL 11673-0266-16 Target 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0107-01 Rite 1 bottle — — FDA listed —
infants fever reducer and pain reliever 160 mg/5mL 11822-0590-01 Rite 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0595-04 Rite 1 bottle — — FDA listed —
infants fever reducer and pain reliever 160 mg/5mL 11822-0766-01 Rite 1 bottle — — FDA listed —
childrens fever reducer and pain reliever 160 mg/5mL 11822-0959-01 Rite 1 bottle — — FDA listed —
MAX relief junior Grape 160 mg/5mL 17856-1123-01 ATLANTIC 72 cups — — FDA listed —
signature care infants pain relief 160 mg/5mL 21130-0178-16 Safeway 1 bottle — — FDA listed —
signature care childrens pain relief 160 mg/5mL 21130-0243-26 Safeway 1 bottle — — FDA listed —
Dye Free Pain Reliever Childrens 160 mg/5mL 21130-0285-04 Safeway, 1 bottle — — FDA listed —
better living brands childrens fever and pain reliver 160 mg/5mL 21130-0746-04 BETTER 1 bottle — — FDA listed —
Childrens Pain Relief Dye free 160 mg/5mL 21130-0910-05 BETTER 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 30142-0590-16 Kroger 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 30142-0766-16 Kroger 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 30142-0818-26 Kroger 1 bottle — — FDA listed —
Topcare pain and fever 160 mg/5mL 36800-0161-10 Topco 1 bottle — — FDA listed —
topcare childrens pain and fever 160 mg/5mL 36800-0202-26 Topco 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0590-16 Topco 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0766-16 Topco 1 bottle — — FDA listed —
topcare infants pain and fever 160 mg/5mL 36800-0946-10 Topco 1 bottle — — FDA listed —
pain relief 160 mg/5mL 37808-0130-26 H 1 bottle — — FDA listed —
Pain and Fever 160 mg/5mL 37808-0161-16 H 1 bottle — — FDA listed —
Pain Relief Childrens Dye Free 160 mg/5mL 37808-0285-04 H 1 bottle — — FDA listed —
Childrens Pain Relief 160 mg/5mL 37808-0482-04 H 1 bottle — — FDA listed —
equaline childrens acetaminophen 160 mg/5mL 41163-0473-26 United 1 bottle — — FDA listed —
Childrens Pain and Fever Dye Free 160 mg/5mL 41226-0779-05 KROGER 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 41226-0910-04 Kroger 1 bottle — — FDA listed —
Pain and Fever 160 mg/5mL 41250-0161-16 Meijer 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0554-26 Meijer 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0590-16 Meijer 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0631-26 Meijer 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 41250-0650-26 Meijer 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0766-16 Meijer 1 bottle — — FDA listed —
pain and fever 160 mg/5mL 41250-0946-10 Meijer 1 bottle — — Discontinued —
childrens pain and fever 160 mg/5mL 41250-0959-26 Meijer 1 bottle — — FDA listed —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0023-26 American 1 bottle — — FDA listed —
CareOne Infants Acetaminophen 160 mg/5mL 41520-0363-10 American 1 bottle — — Discontinued —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0615-26 American 1 bottle — — FDA listed —
careone childrens acetaminophen 160 mg/5mL 41520-0624-26 American 1 bottle — — FDA listed —
CareOne Infants Acetaminophen 160 mg/5mL 41520-0709-10 American 1 bottle — — FDA listed —
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0800-26 American 1 bottle — — FDA listed —
Childrens Pain And Fever 160 mg/5mL 42507-0148-26 HyVee 1 bottle — — FDA listed —
childrens pain and fever 160 mg/5mL 42507-0804-26 HyVee 1 bottle — — FDA listed —
good neighbor pharmacy childrens pain and fever 160 mg/5mL 46122-0210-25 Amerisource 1 bottle — — Discontinued —
equate pain and fever childrens 160 mg/5mL 49035-0042-26 Wal-Mart 1 bottle — — FDA listed —
Equate Childrens Pain and Fever 160 mg/5mL 49035-0313-26 Wal-Mart 1 bottle — — FDA listed —
Parents Choice Infants Pain and Fever 160 mg/5mL 49035-0766-16 Wal-Mart 1 bottle — — FDA listed —
equate pain and fever infants 160 mg/5mL 49035-0946-10 Wal-Mart 1 bottle — — Discontinued —
equate childrens pain and fever 160 mg/5mL 49035-0959-26 Wal-Mart 1 bottle — — Discontinued —
Pain and Fever Childrens 160 mg/5mL 49580-0282-02 P 118 ml — — FDA listed —
Dye Free Pain Reliever Childrens 160 mg/5mL 49580-0685-04 P 1 bottle — — FDA listed —
Pain Relief 160 mg/5mL 49580-0821-04 P 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 49580-2880-04 P 1 bottle — — FDA listed —
Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 160 mg/5mL 50066-0525-24 Genomma 118 ml — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 50090-7254-00 A-S 1 bottle — — FDA listed —
Childrens Tylenol 160 mg/5mL 50580-0139-04 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0154-02 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0170-01 Kenvue 1 bottle — — FDA listed —
TYLENOL For Children Plus Adults 160 mg/5mL 50580-0177-08 Kenvue 1 bottle — — FDA listed —
TYLENOL Extra Strength 960 mg/30mL 50580-0187-08 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0325-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0424-01 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0433-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0509-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0579-02 Kenvue 1 bottle — — FDA listed —
Infants TYLENOL 160 mg/5mL 50580-0599-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0612-01 Kenvue 1 bottle — — FDA listed —
Childrens TYLENOL 160 mg/5mL 50580-0614-01 Kenvue 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0097-19 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0098-19 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0099-19 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0282-04 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 51316-0324-04 CVS 1 bottle — — FDA listed —
Childrens Pain plus Fever Relief 160 mg/5mL 51316-0569-04 CVS 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 51316-0606-16 CVS 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 51316-0643-04 CVS 1 bottle — — FDA listed —
CVS Childrens Pain plus Fever Relief 160 mg/5mL 51316-0695-04 CVS 1 bottle — — FDA listed —
FeverAll 160 mg/5mL 51672-5319-08 Sun 1 bottle — — FDA listed —
Pediacare Childrens Grape 160 mg/5mL 52412-0901-04 RANDOB 1 bottle — — FDA listed —
Pediacare Childrens Acetaminophen Grape 160 mg/5mL 52412-0906-01 RANDOB 1 bottle — — FDA listed —
Fast Acting Pedia Crae 160 mg/5mL 52412-0912-01 Randob 1 bottle — — FDA listed —
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRY 160 mg/5mL 53942-0525-24 DeMoulas 1 bottle — — FDA listed —
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPE 160 mg/5mL 53942-0526-24 DeMoulas 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 53943-0526-24 Discount 118 ml — — FDA listed —
Llorens Care Children Acetaminophen 160 mg/5mL 54859-0850-04 Llorens 118 ml — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 55154-5787-05 Cardinal 5 cups — — FDA listed —
Childrens Pain Relief 160 mg/5mL 55319-0060-36 Family 1 bottle — — FDA listed —
Dye Free Infants Pain and Fever 160 mg/5mL 55319-0206-02 FAMILY 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 55319-0558-08 Family 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 55319-0559-04 Family 1 bottle — — FDA listed —
Family Wellness Childrens Pain Reliever 574 160 mg/5mL 55319-0930-03 Family 1 bottle — — FDA listed —
Dolex Children Pain and Fever 160 mg/5mL 55758-0026-04 Pharmadel 1 bottle — — FDA listed —
dg health childrens pain and fever 160 mg/5mL 55910-0010-26 Dolgencorp 1 bottle — — FDA listed —
DG Health Childrens Pain and Fever 160 mg/5mL 55910-0251-26 Dolgencorp, 1 bottle — — FDA listed —
Pain Relief Childrens 160 mg/5mL 55910-0282-08 Dolgencorp, 1 bottle — — FDA listed —
dg health childrens pain and fever 160 mg/5mL 55910-0738-26 Dolgencorp 1 bottle — — FDA listed —
childrens pain relief 160 mg/5mL 56062-0130-26 Publix 1 bottle — — FDA listed —
pain relief 160 mg/5mL 56062-0590-16 Publix 1 bottle — — FDA listed —
Infants Pain Relief 160 mg/5mL 56062-0766-16 Publix 1 bottle — — FDA listed —
infants pain relief 160 mg/5mL 56062-0946-10 Publix 1 bottle — — FDA listed —
INFANTS Pain and Fever 160 mg/5mL 58602-0168-11 Aurohealth 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 58602-0169-11 Aurohealth 1 bottle — — FDA listed —
INFANTS Pain and Fever 160 mg/5mL 58602-0172-11 Aurohealth 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 58602-0173-11 Aurohealth 1 bottle — — FDA listed —
infants pain fever 160 mg/5mL 59640-0590-16 H 1 bottle — — FDA listed —
infants pain fever 160 mg/5mL 59640-0766-16 H 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 59779-0126-26 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 59779-0308-26 CVS 1 bottle — — FDA listed —
infants pain and fever 160 mg/5mL 59779-0590-16 CVS 1 bottle — — FDA listed —
Pain and Fever Childrens 160 mg/5mL 59779-0785-08 CVS 1 bottle — — FDA listed —
Childrens Acetaminophen Oral Suspension 160 mg/5mL 60687-0762-17 American 10 cups — — FDA listed —
Dr. Cocoa for Children Pain and Fever 160 mg/5mL 62372-0200-04 Infirst 1 bottle — — FDA listed —
Little Remedies Childrens Fever Pain Reliever 160 mg/5mL 63029-0603-02 Medtech 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 63868-0677-60 CHAIN 60 ml — — FDA listed —
Acetaminophen 160 mg/5mL 63868-0678-60 CHAIN 60 ml — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 63941-0282-04 Best 1 bottle — — FDA listed —
Lil Drug Store Childrens Pain and Fever 160 mg/5mL 66715-6956-04 Lil' 1 bottle — — FDA listed —
Childrens Pain Relief Dye-Free 160 mg/5mL 67091-0119-18 WinCo 1 bottle — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 68071-3869-04 NuCare 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 68071-4860-04 NuCare 118 ml — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0030-62 Precision 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0038-58 Precision 10 syringes — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0042-58 Precision 10 syringes — — FDA listed —
Dye Free Childrens Acetaminophen 160 mg/5mL 68094-0061-61 Precision 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0130-58 Precision 10 syringes — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0231-61 Precision 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 68094-0330-61 Precision 10 cups — — FDA listed —
ADWE Childrens Pain Fever 160 mg/5mL 68163-0695-04 RARITAN 1 bottle — — FDA listed —
Childrens Pain Reliever 160 mg/5mL 68391-0288-12 BJWC 3 bottles — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 68788-8397-01 Preferred 1 bottle — — FDA listed —
Good Sense Childrens Pain and Fever 160 mg/5mL 68788-8407-01 Preferred 1 bottle — — FDA listed —
good sense childrens pain and fever 160 mg/5mL 68788-8477-01 Preferred 1 bottle — — FDA listed —
Good Sense Pain and Fever 160 mg/5mL 68788-8646-01 Preferred 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 68998-0525-24 Marc 118 ml — — FDA listed —
Childrens Pain Relief 160 mg/5mL 69168-0455-53 Allegiant 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0041-03 Genexa 5 ml — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0042-09 Genexa 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0084-09 Genexa 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0089-09 Genexa 2 bottles — — FDA listed —
Infants Pain and Fever Cherry Flavor 160 mg/5mL 69676-0097-09 Genexa 1 bottle — — FDA listed —
Genexa Kids Pain and Fever 160 mg/5mL 69676-0099-09 Genexa 1 bottle — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0100-09 Genexa 1 bottle — — FDA listed —
Genexa Infants Pain and Fever 160 mg/5mL 69676-0121-09 Genexa 1 bottle — — FDA listed —
Temperal-ito 160 mg/5mL 69729-0006-02 OPMX 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 69729-0028-02 OPMX 60 ml — — FDA listed —
Temp X 160 mg/5mL 69729-0047-02 OPMX 60 ml — — FDA listed —
Mejoralito 160 mg/5mL 69729-0068-02 OPMX 60 ml — — FDA listed —
Neo-Lubrina 160 mg/5mL 69729-0118-04 OPMX 1 bottle — — FDA listed —
Desenfriol-Ito Plus 160 mg/5mL 69729-0815-04 OPMX 1 bottle — — FDA listed —
Mejoralito Children 160 mg/5mL 69729-0825-04 OPMX 1 bottle — — FDA listed —
Neo-Lubrina Children 160 mg/5mL 69729-0827-04 OPMX 1 bottle — — FDA listed —
childrens pain and fever 160 mg/5mL 69842-0959-26 CVS 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 70677-1286-01 Strategic 473 ml — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 71205-0263-04 Proficient 1 bottle — — FDA listed —
Good Sense Childrens Pain and Fever 160 mg/5mL 71205-0601-04 Proficient 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 71335-2722-01 Bryant 1 bottle — — FDA listed —
MAX relief junior 160 mg/5mL 71399-0020-04 Akron 1 bottle — — FDA listed —
MAX relief junior 160 mg/5mL 71399-0021-04 Akron 1 bottle — — FDA listed —
MAX relief junior Grape 160 mg/5mL 71399-0022-04 Akron 1 bottle — — FDA listed —
MAX relief junior 160 mg/5mL 71399-0038-04 Akron 1 bottle — — FDA listed —
MAX relief junior Grape 160 mg/5mL 71399-0048-02 Akron 1 bottle — — FDA listed —
Mommys Bliss Childrens Pain and Fever 160 mg/5mL 71444-0793-01 Mom 118 ml — — FDA listed —
Mommys Bliss Infants Pain and Fever 160 mg/5mL 71444-0893-01 Mom 59 ml — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 72162-2279-02 Bryant 1 bottle — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0105-26 Amazon.com 1 bottle — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0130-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens pain and fever 160 mg/5mL 72288-0175-26 Amazon.com 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0590-16 Amazon.com 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0766-16 Amazon.com 1 bottle — — FDA listed —
basic care infants pain and fever 160 mg/5mL 72288-0946-16 Amazon.com 1 bottle — — FDA listed —
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0959-26 Amazon.com 1 bottle — — FDA listed —
Careone Infants Acetaminophen 160 mg/5mL 72476-0766-16 Retail 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76162-0079-36 TOPCO 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76281-0525-24 AptaPharma 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 76281-0526-24 AptaPharma 1 bottle — — FDA listed —
Pain Reliever 160 mg/5mL 79903-0172-04 WALMART 1 bottle — — FDA listed —
equate infants pain and fever 160 mg/5mL 79903-0225-02 WALMART 1 bottle — — FDA listed —
Pain Relief Fever Reducer children 160 mg/5mL 80272-0002-04 Ellywell, 1 bottle — — FDA listed —
CHILDRENS Acetaminophen 160 mg/5mL 81033-0026-01 Kesin 100 cups — — FDA listed —
Childrens Acetaminophen Dye Free Grape 160 mg/5mL 81522-0285-04 FSA 1 bottle — — FDA listed —
KOSHER MEDS Childrens Pain and Fever 160 mg/5mL 82179-0002-04 Mollec 1 bottle — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 82568-0010-02 AARNA 60 ml — — FDA listed —
Infants Pain and Fever 160 mg/5mL 82673-0096-02 KinderFarms, 1 bottle — — FDA listed —
Pain and Fever Childrens 160 mg/5mL 82673-0097-04 KinderFarms, 1 bottle — — FDA listed —
Infants Pain and Fever 160 mg/5mL 82673-0098-02 KinderFarms, 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 82673-0104-04 KinderFarms, 1 bottle — — FDA listed —
Revasol Acetaminophen Suspension 160 mg/5mL 84379-0311-16 Rnv 474 ml — — FDA listed —
Revasol Acetaminophen Suspension Dye Free 160 mg/5mL 84379-0357-16 Rnv 474 ml — — FDA listed —
Childrens Acetaminophen 160 mg/5mL 85828-0922-05 Grocery 1 bottle — — FDA listed —
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL 160 mg/5mL 87078-0121-52 MEDWISE 12 pouches — — FDA listed —
OneSsip Acetaminophen 160 mg/5mL 87078-0131-52 MEDWISE 12 pouches — — FDA listed —
Panadol 160 mg/5mL 00135-0539-02 Haleon 1 bottle — — FDA listed —
Panadol 160 mg/5mL 00135-0537-01 Haleon 1 bottle — — FDA listed —
Infants Pain And Fever 160 mg/5mL 72288-0157-16 Amazon.com 1 bottle — — FDA listed —
Good Sense Infants Pain And Fever 160 mg/5mL 00113-9523-16 L. 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0165-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0166-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0164-20 Aurohealth 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0171-20 Aurohealth 1 bottle — — FDA listed —
KinderFarms Childrens Pain and Fever 160 mg/5mL 82673-0108-04 KinderFarms, 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 58602-0167-20 Aurohealth 1 bottle — — FDA listed —
KinderFarms Infants Pain and Fever 160 mg/5mL 82673-0100-02 KinderFarms, 1 bottle — — FDA listed —
Genexa Kids Pain and Fever 160 mg/5mL 69676-0101-09 Genexa 1 bottle — — FDA listed —
Childrens Pain And Fever 160 mg/5mL 72288-0702-34 Amazon.com 1 bottle — — FDA listed —
Pain Relief Childrens 160 mg/5mL 67091-0466-04 WinCo 1 bottle — — FDA listed —
Desenfriol-Ito Plus 160 mg/5mL 69729-0835-02 OPMX 1 bottle — — FDA listed —
Pentrexcilina 160 mg/5mL 69729-0824-02 OPMX 1 bottle — — FDA listed —
Mejoralito 160 mg/5mL 69729-0823-02 OPMX 1 bottle — — FDA listed —
Up And Up Childrens Acetaminophen 160 mg/5mL 82442-0151-34 Target 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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 83474-0001-04, 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
496
Units reimbursed last 4 qtrs
93.4K
Gross reimbursed last 4 qtrs
$3.1K
Avg / prescription
$6.33
Avg / unit
$0.0336
Latest quarter Q4 2025
74Rx
Medicaid pays / mL
$0.0336
gross reimbursed
vs
NADAC / mL
$0.0214
acquisition cost
=
Spread
+$0.0122
+57% 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 ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 496 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: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported 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: no data reported IN Ohio: no data reported OH Pennsylvania: 22,247 units · 172 per 100k residents PA New Jersey: 71,123 units · 766 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported 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: no data reported 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
172766
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 766 /100k
2 Pennsylvania 172 /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 ACETAMINOPHEN — the ingredient across all brands.

Top reported reactions

Pain49,512
Fatigue45,791
Nausea41,932
Overdose40,941
Drug Dependence39,209
Headache38,738
Death36,479

Age at onset

Neonate2,511
Infant1,510
Child4,320
Adolescent3,245
Adult56,522
Elderly41,990

Reporter sex

679,604 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization199,486
Death102,045
Life-threatening29,552
Disabling25,685
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 53,488 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
83474-0001-04 You're viewing this 1 BOTTLE in 1 CARTON (83474-001-04) / 118 mL in 1 BOTTLE 2024-03-28 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

⏱️ Dosage and Administration 168 words ▾

Directions ■ this product does not contain directions or complete warnings for adult use. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product.

Do not use any other dosing device.

⚠️ Warnings 96 words ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen 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.

🆘 Overdosage 51 words ▾

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

🧪 Active Ingredient 12 words ▾

Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

🎯 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 ↗
← 83468-0070-03 · Milestone 83474-0002-04 · Puro →
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.