ACETAMINOPHEN ORAL SUSPENSION

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

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 coldfluheadachesore throattoothache

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:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

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 your child 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

These could be signs of a serious condition

• 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

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 give more than 5 times in 24 hours

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

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC 68094-130-582.5 mL per unit dose syringeFifty (50) syringes per shipper

NDC 68094-231-585 mL per unit dose syringeFifty (50) syringes per shipper

NDC 68094-231-615 mL per unit dose cupOne hundred (100) cups per shipper

NDC 68094-231-625 mL per unit dose cupThirty (30) cups per shipper

NDC 68094-330-6110.15 mL per unit dose cupOne hundred (100) cups per shipper

NDC 68094-330-6210.15 mL per unit dose cupThirty (30) cups per shipper

NDC 68094-030-6220.3 mL per unit dose cupThirty (30) cups per shipper

SPL UNCLASSIFIED SECTION

Packaged ByPrecision Dose, Inc.South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1263 Rev. 04/23