Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscle aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever
Acetaminophen Oral Solution, USP 325 mg/10.15 mL
- Manufacturer
- VistaPharm, LLC
- Effective date
- 2022-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:44:00
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
■ do not take more than directed (see overdose warning) ■ do not take more than 8 doses in any 24-hour period ■ dose as follows or as directed by doctor ■ take only with dosing cup provided ■ adults and children 12 years of age and older: 10.15 mL (325 mg) every 3 - 4 hours ■ children under 12 years of age: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 10.15 mL)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscle aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever
Warnings
SPL UNCLASSIFIED SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4000 mg in 24 hours
■ with other drugs containing acetaminophen
■ 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.
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 acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are 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
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
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
■ do not take more than directed (see overdose warning)
■ do not take more than 8 doses in any 24-hour period
■ dose as follows or as directed by doctor
■ take only with dosing cup provided
■ adults and children 12 years of age and older: 10.15 mL (325 mg) every 3 - 4 hours
■ children under 12 years of age: ask a doctor
Other information
■ each 10.15 mL contains: sodium 16 mg
■ store at 20 -25°C (68 -77°F)
■ do not use if foil on cup is missing or torn
Inactive ingredients
anhydrous citric acid, FD&C blue no. 1, FD& C red no. 40, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin
Questions or comments?
Call 1-888-655-1505
How Supplied
NDC 66689-055-01: 10.15 mL unit-dose cup
NDC 66689-055-99: Case contains 100 unit-dose cups of 10.15 mL (NDC 66689-055-01), packaged in 10 trays of 10 unit-dose cups each.
Distributed by:
VistaPharm Inc.
Largo, FL 33771, USA
VP2511
10/2019
Principal Display Panel - 10.15 mL Lidding Label
ACETAMINOPHEN Oral Solution, USP
325 mg per 10.15 mL
[160 mg/5 mL]
Alcohol-Free
Delivers 325 mg [10.15 mL]
Store at 20°-25°C (68°-77°F); [see USP CRT conditions].
Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
NDC 66689-055-01
VP2155R2
02/18
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-055-99 | 2022-12-19 | C162847 | 48780-1 | e4f33bdf-b21d-d8a0-e053-dadaa90a6e4e | Acetaminophen Oral Solution, USP 325 mg/10.15 mL |
| 66689-055-99 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b21d-d8a0-e053-dadaa90a6e4e | Acetaminophen Oral Solution, USP 325 mg/10.15 mL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-055-01 | ML - Milliliter | 66689-055 | d08c41ae-5194-447b-ae26-710c3de63e9b | 1 | 2018-06-11 |
| 66689-055-99 | ML - Milliliter | 66689-055 | 915444d9-6608-4473-8f47-048074c16c93 | 1 | 2018-06-11 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 300
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66689-055 | 66689-055-01, 66689-055-99 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | 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 |
|---|---|---|---|---|---|---|
| 69766062-189f-447c-8385-aa4a9d664a62 | a10f53fe-4312-406d-a0a5-3bbb89f4c0c5 | 2022-12-19 | Warnings | 69766062-189f-447c-8385-aa4a9d664a62 a10f53fe-4312-406d-a0a5-3bbb89f4c0c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.