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
- Precision Dose, Inc. | L Perrigo Company
- Effective date
- 2025-08-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- full-release
- Hydrated at
- 2026-06-01 01:12:29
Label at a glance#
ProductAcetaminophen
Active ingredientAcetaminophen
Label structure16 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 3 mg store at 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Grape Flavor
80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL
650 mg/20.3 mL
For Hospital Use Only
LI1650 Rev. 10/24
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 your child has 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 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 3 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
Questions or comments?
1-800-397-9228
SPL UNCLASSIFIED SECTION
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
How Supplied
NDC 68094-042-58
2.5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper
NDC 68094-038-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper
NDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper
NDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper
NDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper
NDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper
NDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper
NDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper
NDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper
SPL UNCLASSIFIED SECTION
Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com
LI1650 Rev. 10/24
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
NDC 68094-231-59
PrecisionDose™
ACETAMINOPHEN
Oral Suspension
160 mg/5 mL
Pkg: Precision Dose, Inc., S. Beloit, IL 61080
PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
ACETAMINOPHEN ORAL SUSPENSION
160 mg / 5 mL
Delivers 5 mL
Store at 20-25°C (68-77°F)
Hospital Use Only • Alcohol Free
Aspirin Free • Gluten Free • Ibuprofen Free
For Oral Use Only
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label
NDC 68094-330-59
PrecisionDose™
ACETAMINOPHEN
Oral Suspension
325 mg/10.15 mL
Delivers 10.15 mL
Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free
Aspirin Free
Gluten Free
Ibuprofen Free
Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
South Beloit, IL 61080
1303 R1
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
NDC 68094-030-59
PrecisionDose™
ACETAMINOPHEN
Oral Suspension
650 mg/20.3 mL
Delivers 20.3 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Gluten Free Ibuprofen Free
Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1262 R1
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 14 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 14 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 14 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 14 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 14 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 14 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 14 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68094-030-59 | Acetaminophen | 20.3 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 20.3 | 14 | |
| 68094-030-62 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 14 | |
| 68094-030-62 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 14 | |
| 68094-231-01 | Acetaminophen | 5 mL in 1 SYRINGE, PLASTIC | SUSPENSION | 5 | 14 | |
| 68094-231-58 | Acetaminophen | 5 in 1 CASE | SUSPENSION | 5 | 14 | |
| 68094-231-58 | Acetaminophen | 10 in 1 BAG | SUSPENSION | 10 | 14 | |
| 68094-231-59 | Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 14 | |
| 68094-231-61 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 14 | |
| 68094-231-61 | Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 14 | |
| 68094-231-62 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 14 | |
| 68094-231-62 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 14 | |
| 68094-330-59 | Acetaminophen | 10.15 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10.15 | 14 | |
| 68094-330-61 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 14 | |
| 68094-330-61 | Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 14 | |
| 68094-330-62 | Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 14 | |
| 68094-330-62 | Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 14 |
DailyMed Billing Units#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- anhydrous citric acid
- butylparaben
- calcium sulfate, unspecified form
- carrageenan
- D&C red no. 33
- FD&C blue no. 1
- glycerin
- high fructose corn syrup
- microcrystalline cellulose
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- propylene glycol
- water
- sodium benzoate
- sorbitol
- sodium phosphate, tribasic
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68094-231 | 68094-231-59, 68094-231-62, 68094-231-61, 68094-231-01, 68094-231-58 |
| 68094-330 | 68094-330-59, 68094-330-62, 68094-330-61 |
| 68094-030 | 68094-030-59, 68094-030-62 |
| 0113-0212 |
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 | Precision Dose, Inc. | e1d4f562-433c-4344-9b77-1a7c731d1be5 | 2025-08-29 | Warnings | 68094-231-59 68094-330-61 68094-030-59 68094-231-62 68094-231-01 68094-330-62 68094-231-58 68094-330-59 68094-030-62 68094-231-61 68094-231 68094-330 68094-030 68094033061 68094023159 68094033062 68094023101 68094023158 68094003059 68094003062 68094023162 68094023161 68094033059 969e07e8-8e42-47bc-a77b-0ff7893d3175 e1d4f562-433c-4344-9b77-1a7c731d1be5 |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | c6b79501-d08b-4430-9545-70da5f545975 | 2024-12-03 | Warnings | 0113-0212 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.