Indications and uses
• for the temporary relief of minor aches and pains due to headache muscular aches backache sore throat flu the common cold toothache premenstrual and menstrual cramps • for the minor pain from arthritis • and to reduce fever
Acetaminophen Oral Solution USP Alcohol Free/Dye Free/Sugar Free Grape Flavored
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Effective date
- 2025-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:21:49
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections
Dosage and administration
do not take more than directed (see overdose warning ) dose product from the single dose cup the product is packaged in mL=milliliter 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 under 12 years of age consult a doctor
Storage and handling
■ Each 20.3 mL contains: sodium 24 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#
Active ingredient (in each 20.3 mL)
Acetaminophen 650 mg
Purposes
Pain reliever/fever reducer
Uses
• for the temporary relief of minor aches and pains due to
- headache
- muscular aches
- backache
- sore throat
- flu
- the common cold
- toothache
- premenstrual and menstrual cramps
• for the minor pain from arthritis
• and to reduce fever
Warnings
SPL UNCLASSIFIED SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if, you take
- more than 6 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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 are allergic to aetaminophen or any of the inactive ingredients of this product
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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OVERDOSAGE SECTION
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.
Directions
- do not take more than directed (see overdose warning)
- dose product from the single dose cup the product is packaged in
- mL=milliliter
| 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 under 12 years of age | consult a doctor |
Other information
■ Each 20.3 mL contains: sodium 24 mg
■ store at 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate
Questions or comments?
Call 1-800-845-8210. You may also report serious side effects to this phone number.
Distributed by:
PAI Pharma
Greenville,SC 29605
www.paipharma.com
R05/25
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup
Delivers 20.3 mL
NDC 0121-3141-21
Acetaminophen
Oral Solution USP
650 mg/20.3 mL
Pain Reliever/Fever Reducer
Alcohol Free/Dye Free/Sugar Free
Grape Flavored
Package Not Child-Resistant
Dist. by: PAI Pharma
GREENVILLE, SC 29605
See insert for drug facts
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 2 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 2 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 2 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 2 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Code 128 | (01)00301213141215 | GTIN-14: 00301213141215 GTIN-12: 301213141215 UPC-A: 301213141215 EAN-13: 0301213141215 GTIN storage (14 digits): 00301213141215 | apap-fn1047-20_3ml-1.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-3141-00 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 2 | |
| 0121-3141-00 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 2 | |
| 0121-3141-21 | Acetaminophen | 20.3 mL in 1 CUP, UNIT-DOSE | SOLUTION | 20.3 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-3141-00 | ML - Milliliter | 0121-3141 | 4d11737d-d657-41a1-a5b5-7818a9f4592c | 1 | 2026-01-08 |
| 0121-3141-21 | ML - Milliliter | 0121-3141 | 30e1dd06-e541-4840-b0a5-2e9a49c5cba0 | 1 | 2026-01-08 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SODIUM BENZOATE
- SODIUM METABISULFITE
- SORBITOL
- SUCRALOSE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-3141 | 0121-3141-21, 0121-3141-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
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 | 33599f18-5f49-4f22-8a77-a072115763ef | 2025-12-11 | Warnings | 0121-3141-21 0121-3141-00 0121-3141 00121314121 00121314100 22f3cd3e-34e9-4682-9534-fedffb7494a4 33599f18-5f49-4f22-8a77-a072115763ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.