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 160 mg/5 mL
- Manufacturer
- VistaPharm, LLC
- Effective date
- 2022-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:43:59
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 4 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: 20 mL (640 mg) in dosing cup every 6 hours ■ children under 12 years of age: ask a doctor
Storage and handling
■ each 5 mL contains: sodium 8 mg ■ store at 20 -25°C (68 -77°F) ■ do not use if foil on cup is missing or torn
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen 160 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
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.
OTC - DO NOT USE SECTION
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.
SPL UNCLASSIFIED SECTION
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 4 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: 20 mL (640 mg) in dosing cup every 6 hours
■ children under 12 years of age: ask a doctor
Other information
■ each 5 mL contains: sodium 8 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 66689-054-01: 5 mL unit-dose cup
NDC 66689-054-99: Case contains 100 unit-dose cups of 5 mL (NDC 66689-054-01), packaged in 10 trays of 10 unit-dose cups each.
Distributed by:
VistaPharm Inc.
Largo, FL 33771, USA
VP2510
10/2019
Principal Display Panel - 5 mL Lidding Label
ACETAMINOPHEN Oral Solution, USP
160 mg per 5 mL
Alcohol-Free
Delivers 160 mg [5 mL]
Store at 20°- 25°C (68°-77°F); [See USP CRT conditions].
Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
NDC 66689-054-01
VP2154R2
02/18
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-054-99 | 2022-12-19 | C162847 | 48780-1 | e4f33bdf-b31f-d8a0-e053-dadaa90a6e4e | Acetaminophen Oral Solution, USP 160 mg/5 mL |
| 66689-054-99 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b31f-d8a0-e053-dadaa90a6e4e | Acetaminophen Oral Solution, USP 160 mg/5 mL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-054-01 | ML - Milliliter | 66689-054 | 3010e0a7-0dd9-4355-9bc9-b473e02f9f23 | 1 | 2018-06-11 |
| 66689-054-99 | ML - Milliliter | 66689-054 | 7259ebdb-7467-494c-bb1e-61dd68685c6f | 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 |
|---|---|
| 66689-054 | 66689-054-01, 66689-054-99 |
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 |
|---|---|---|---|---|---|---|
| 0e43d29f-a0e9-46c7-8085-84957a23f01e | 7955c2f7-38fd-4e78-87b9-a35638dea0c2 | 2022-12-19 | Warnings | 0e43d29f-a0e9-46c7-8085-84957a23f01e 7955c2f7-38fd-4e78-87b9-a35638dea0c2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.