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Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL Liquid, 473 mL — NDC 82568-0009-06 package photo

Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL Liquid, 473 mL

by AARNA USA INC. · 473 mL in 1 BOTTLE (82568-0009-6)
NDC 82568-0009-06
🏷️ FDA NDC (as labeled) 82568-0009-6 billing pads the package segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Also comes in: 118 mL 82568-0009-04 236 mL 82568-0009-08
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) 82568-0009-6
Product NDC 82568-0009
11-digit billing NDC 82568000906
RxCUI 307675
UNII 362O9ITL9D
Application # M013
SPL Set ID 39347f5d-2d3c-0c23-e063-6294a90a3a46
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN
GPI-14 64200010000912
Why two NDCs? The FDA registers this code as 82568-0009-6 — a 5-4-1 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 package segment → 82568-0009-06. 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

LabelerAARNA USA INC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code82568
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio19 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

📖 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

FlavorGrape
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 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesAnhydrous Citric Acid, D&C Red No 33, FD&C Blue No 1, Glycerin, Grape Flavor, Polyethylene Glycol 400, Purified Water, Sodium Benzoate,  Sodium Citrate, Sorbitol Solution, 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 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.
Try another pack size: 118 mL 236 mL
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/5mL 54859-0809-16 LLORENS 473 ml $0.011 — Availability likely —
Acetaminophen 160 mg/5mL 57237-0304-12 Rising 118 ml $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0524-04 Method 120 ml $0.024 — Availability likely —
Acetaminophen 160 mg/5mL 69367-0323-04 Westminster 118 ml $0.024 — Availability likely —
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0525-04 Method 120 ml $0.040 — FDA listed —
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/5mLthis 82568-0009-06 AARNA 473 ml — — 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

🏛️
2024
On the market since
Jul 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.

📊 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 Childrens Acetaminophen Oral Liquid Grape Flavor (this brand).

Top reported reactions

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

Age at onset

Neonate562
Infant376
Child2,615
Adolescent2,132
Adult26,646
Elderly17,765

Reporter sex

253,624 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,315
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 28,189 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
82568-0009-04 1 BOTTLE in 1 CARTON (82568-0009-4) / 118 mL in 1 BOTTLE 2024-07-01 Active
82568-0009-06 You're viewing this 473 mL in 1 BOTTLE (82568-0009-6) 2024-07-01 Active
82568-0009-08 1 BOTTLE in 1 CARTON (82568-0009-8) / 236 mL in 1 BOTTLE 2024-07-01 Active

Pack size FAQ

What quantity is in NDC 82568-0009-06?
NDC 82568-0009-06 contains 473 mL — 473 ml in 1 bottle.
What NDC number is used to bill for this package of Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL Liquid?
Bill NDC 82568-0009-06 — the 11-digit billing format is 82568000906. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 82568-0009-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82568-0009-06, written without dashes as 82568000906. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82568-0009-06, the first segment (82568) is the labeler code FDA assigned to AARNA USA INC.; the middle segment (0009) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AARNA USA INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (82568-0009-04), 1 bottle (82568-0009-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
AARNA USA INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

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

Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)

⏱️ Dosage and Administration 144 words ▾

Directions this product does not contain directions or complete warnings for adult use shake well before using mL = milliliter find right dose on chart below. if possible, use weight to dose, otherwise use age use only the enclosed dosing cup designed for use with product. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours. Weight (lbs) Age (yrs.) Dose (tsp or mL) Weight (lbs) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 48 to 59 6 to 8 2 tsp or 10 mL 25 to 35 2 to 3 1 tsp or 5 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 72 to 95 11 3 tsp or 15 mL

⚠️ Warnings ~1 min read ▾

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more then 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, persist or 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 your child is allergic to acetaminophen or anyof the inactive ingredients in this product.

Ask a doctor or pharmacist before use if the child has liver disease. Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if pain gets worse or lasts for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present.

These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Keep out of Reach of children

📦 Storage and Handling 14 words ▾

Other Information Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

🧪 Active Ingredient 14 words ▾

Active Ingredient Active ingredient (in each 5mL) Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

🧪 Inactive Ingredients 28 words ▾

Inactive Ingredients Anhydrous Citric Acid, D&C Red No 33, FD&C Blue No 1, Glycerin, Grape Flavor, Polyethylene Glycol 400, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

🎯 Purpose 19 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82568-0008-04 · AARNA 82568-0010-02 · AARNA →
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.