Acetaminophen
650 mg/20.3mL · Solution
- Available without prescription
- Active substance
- Acetaminophen
- Made by
- PAI Holdings, LLC dba PAI Pharma
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-08-12
Pain reliever/fever reducer
- Headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
Full directions ↓With any other drug containing acetaminophen (prescription or nonprescription).
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
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
From the official label · 2024-08-12 · DailyMed
How it works
From the US prescribing label for the same active substance (Acetaminophen). It describes the substance, not this exact product.
The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.
With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates.
Acetaminophen metabolites are mainly excreted in the urine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-28
Do not take it if
- with any other drug containing acetaminophen (prescription or nonprescription).
- if you are not sure whether a drug contains acetaminophen,
- ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor
- if you are allergic to acetaminophen or any of the inactive ingredients of this product
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- do not take more than directed (see overdose warning ) age dose
- adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
- children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
- children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
- children 2 to under 4 years of age 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
- children under 2 years of age consult a doctor
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
the user has liver disease
Quoted from the official label, section “OTC — Ask Doctor”.
Ask a pharmacist first if
the user is taking the blood thining drug warfarin.
Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.
Stop and get help if
symptoms do not improve new symptoms occur pain or fever persists or gets worse
Quoted from the official label, section “OTC — Stop Use”.
Other 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 taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert:
- Acetaminophen may cause severe skin reactions.
- Symptoms may include:
- skin reddening blisters rash If a skin reaction occurs,
- stop use and seek medical help right away.
- Sore throat warning:
- If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- Do not use with any other drug containing acetaminophen (prescription or nonprescription).
- Ask a doctor before use if the user has liver disease
- Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.
- Stop use and
- ask a doctor
- if symptoms do not improve new symptoms occur pain or fever persists or gets worse If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- 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 children even
- if you do not notice any signs or symptoms.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
How to store it
- Each 5 mL contains: sodium 2 mg
- store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
- keep tightly closed
- protect from light
- a red, cherry flavored solution supplied in the following oral dosage forms:
- NDC 0121-0657-05:
- 5 mL unit dose cup NDC 0121-0657-00:
- Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1314-11:
- 10.15 mL unit dose cup NDC 0121-1314-00:
- Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1971-21:
- 20.3 mL unit dose cup NDC 0121-1971-00:
- Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Pain reliever/fever reducer
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
Call 1-800-845-8210. You may also report serious side effects to this phone number.
Quoted from the official label, section “OTC — Questions”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Colour dyes
FD&C Red No. 40
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugars
sucrose
Relevant to diabetes and dental health. - Sugar alcohols
sorbitol
Sorbitol and similar can upset the stomach and matter with fructose intolerance.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (6)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 6 of 6
- AcetaminophenThis oneWithout prescriptionPAI Holdings, LLC dba PAI PharmaColour dyesSugarsSugar alcohols
- AcetaminophenWithout prescriptionAmerican Health PackagingColour dyesSugarsSugar alcohols
- AcetaminophenWithout prescriptionCardinal Health 107, LLCColour dyesSugarsSugar alcohols
- AcetaminophenWithout prescriptionMajor PharmaceuticalsColour dyesSugarsSugar alcohols
- AcetaminophenWithout prescriptionPAI Holdings, LLC dba PAI PharmaSugarsSugar alcoholsParabens
- Acetaminophen SolutionWithout prescriptionPatrin Pharma, Inc.Colour dyesSugar alcohols
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | PAI Holdings, LLC dba PAI Pharma |
|---|---|
| Active substance | Acetaminophen |
| Strength | 650 mg/20.3mL |
| Form | Solution |
| Route | Oral |
| Packs | 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE |
| NDC | 0121-1971 |
| NDC | 0121-3141 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
175 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet76 products
.5 g/g2
.5 g/g · 2 companies
160 mg2
160 mg · 2 companies
- 250 mg + 125 mg
- Tablet, Extended Release17 products
- Solution14 products
160 mg/5mL4
325 mg/10.15mL3
325 mg/10.15mL · 3 companies
650 mg/20.3mL4
650 mg/20.3mL · 4 companies
- American Health Packaging
- Cardinal Health 107, LLC
- Major Pharmaceuticals
- PAI Holdings, LLC dba PAI Pharma · this page
1000 mg/30mL3
1000 mg/30mL · 3 companies
- Tablet, Coated14 products
Show all forms · 12 forms
- Tablet, Film Coated14 products
- Injection, Solution14 products
- Tablet, Film Coated, Extended Release8 products
- Suspension7 products
160 mg/5mL5
- 325 mg/10.15mL
- 650 mg/20.3mL
- Injection5 products
10 mg/mL3
10 mg/mL · 3 companies
1000 mg/100mL2
1000 mg/100mL · 2 companies
- Liquid4 products
160 mg/5mL4
160 mg/5mL · 4 companies
- Capsule, Liquid Filled1 products
- Syrup1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.