FDA Label for Acetaminophen
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 2.5 ML SYRINGE LABEL
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Precision Dose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
LI1593 Rev. 06/23
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 your child has ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if your child 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 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 give 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 68094-130-58
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
Principal Display Panel - 2.5 Ml Syringe Label
ACETAMINOPHEN ORAL SUSPENSION
80 mg / 2.5 mL Delivers 2.5 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
* Please review the disclaimer below.