Acetaminophen Oral Suspension

SPL v6

SPL

SPL Set ID b16e5dcf-b290-4ff2-a150-4b875647ec9a

Route

ORAL

Published

Effective Date 2025-02-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-07-31

Description

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

Purpose

Pain reliever/fever reducer

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

Medication Information

Purpose

Pain reliever/fever reducer

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

Description

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

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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

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

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.

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

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.

Other Information

each 5 mL contains: sodium 3 mg
store at 20-25°C (68-77°F)

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.

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

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

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

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

Structured Label Content

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

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

Do Not Use (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