Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Acetaminophen Oral Suspension
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Effective date
- 2025-08-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:11:00
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections
Dosage and administration
Use as directed per healthcare professional. do not take more than directed (see overdose warning ) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not take more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor Under 24 Under 2 years ask a doctor 24-35 2-3 years 5 mL 3...
Storage and handling
each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F)
Contacts and useful links#
Websitewww.paipharma.com
www.paipharma.com
www.paipharma.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- 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). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
- do not give this product to children for the pain of arthritis unless directed by a doctor
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- Use as directed per healthcare professional.
- do not take more than directed (see overdose warning)
- shake well before using
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not take more than 5 times in 24 hours
| Weight (lb) | Age (yr) | Dose (mL) * |
|---|---|---|
| Under 24 | Under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
| Over 96 | adults and children 12 years and over | 20 mL |
* or as directed by a doctor
Other information
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
Inactive ingredients
acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.
SPL UNCLASSIFIED SECTION
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
How Supplied
- grape flavored suspension supplied in the following oral dosage forms:
NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups.
NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
OTC - QUESTIONS SECTION
Call 1-800-845-8210.
MANUFACTURED BY
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
NDC 0121-0941-05
ACETAMINOPHEN ORAL SUSPENSION
160 mg per 5 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label
NDC 0121-1882-11
ACETAMINOPHEN ORAL SUSPENSION
325 mg per 10.15 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
NDC 0121-2823-21
ACETAMINOPHEN ORAL SUSPENSION
650 mg per 20.3 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 5 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 5 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 5 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 5 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 5 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 5 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 5 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0941-00 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 5 | |
| 0121-0941-00 | Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 5 | |
| 0121-0941-05 | Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 5 | |
| 0121-0941-94 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 5 | |
| 0121-0941-94 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 5 | |
| 0121-1882-00 | Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 5 | |
| 0121-1882-00 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 5 | |
| 0121-1882-11 | Acetaminophen | 10.15 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10.15 | 5 | |
| 0121-1882-94 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 5 | |
| 0121-1882-94 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 5 | |
| 0121-2823-21 | Acetaminophen | 20.3 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 20.3 | 5 | |
| 0121-2823-94 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 5 | |
| 0121-2823-94 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1882-00 | ML - Milliliter | 0121-1882 | 915601a4-7a0b-4531-b57f-9d407992a1a5 | 1 | 2022-01-06 |
| 0121-1882-11 | ML - Milliliter | 0121-1882 | d4a8f39f-9bc5-4087-bad3-a8241fd3d175 | 1 | 2022-01-06 |
| 0121-1882-94 | ML - Milliliter | 0121-1882 | 7d77be84-bdf9-4f87-a1e5-1f4c858b8efb | 1 | 2022-01-06 |
| 0121-2823-21 | ML - Milliliter | 0121-2823 | 718f60b6-0027-4acc-9dfd-b7d15553ffbb | 1 | 2022-01-06 |
| 0121-2823-94 | ML - Milliliter | 0121-2823 | fcc3545e-3a08-4bc7-a690-dfb8483128be | 1 | 2022-01-06 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- ACESULFAME POTASSIUM
- BUTYLPARABEN
- ANHYDROUS CITRIC ACID
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- POLYSORBATE 80
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL SOLUTION
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-0941 | 0121-0941-05, 0121-0941-94, 0121-0941-00 |
| 0121-1882 | 0121-1882-11, 0121-1882-94, 0121-1882-00 |
| 0121-2823 | 0121-2823-21, 0121-2823-94 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | caf5daea-409e-5dd2-e053-2995a90acb12 | 2025-08-18 | Warnings | 0121-2823-94 0121-0941-00 0121-1882-11 0121-1882-94 0121-1882-00 0121-2823-21 0121-0941-05 0121-0941-94 0121-0941 0121-1882 0121-2823 00121188200 00121188294 00121188211 00121282394 00121094194 00121282321 00121094100 00121094105 bbd6f65a-a6ec-4c17-935c-ed743c45e2c8 caf5daea-409e-5dd2-e053-2995a90acb12 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.