Other
Drug Facts
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
Distributed By
Perrigo
Allegan, MI 49010
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
LI1263 Rev. 06/20
Acetaminophen Suspension
FDA Label NDC 68094-330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose, Inc. for the product Acetaminophen (NDC 68094-330). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if the user has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Otc - When Using
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
- do not give this product to children for the pain of arthritis unless directed by a doctor
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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) or as directed by a doctor |
|---|---|---|
| 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 |
Other Information
- each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, butylparaben, 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
How Supplied
NDC 68094-042-58
2.5 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 68094-038-58
5 mL per unit dose ENFit 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
Otc - Questions
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
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 R0
Principal Display Panel (20.3 mL Cup Label)
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 R0
Principal Display Panel (10.15 mL Cup Label)
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 Cup Label)
* Please review the disclaimer below.
