Acetaminophen
ACETAMINOPHEN ORAL SUSPENSION
e1d4f562-433c-4344-9b77-1a7c731d1be5
HUMAN OTC DRUG LABEL
Aug 29, 2025
Precision Dose, Inc.
DUNS: 035886746
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
WARNINGS SECTION
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
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
When using this product do not exceed recommended dose (seeoverdose 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
If pregnant or breast-feeding, ask a health professional before use.
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.
DOSAGE & ADMINISTRATION SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
*each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
1-800-397-9228