655l Walgreens Acetaminophen 160 Mg Suspension Infants

655l Walgreens Acetaminophen 160 Mg Suspension Infants
SPL v2
SPL
SPL Set ID 281a530b-c759-50eb-e063-6394a90abb4f
Route
ORAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Glycerin Sucralose Fd&c Red No. 40 Sucrose Sorbitol Solution Water Hydroxyethyl Cellulose, Unspecified Carboxymethylcellulose Sodium, Unspecified Form Sodium Benzoate Xanthan Gum Anhydrous Citric Acid Propylparaben Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-03

Description

Active ingredient (in each 5 mL) Acetaminophen 160 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

■ more than 5 doses in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

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.

Indications and Usage

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

- the common cold

- flu

- headache

- sore throat

- toothache

Dosage and Administration

Directions

Do not take more than directed.

See overdose warning

this product does not contain directions or complete warnings for adult use.

shake well before using

■ mL = milliliter

■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.

■ push air out of syringe. Insert syringe tip into the bottle opening

■ flip bottle upside down. Pull yellow part of syringe to correct dose

■ dispense liquid slowly into child’s mouth, toward inner cheek

■ repeat dose every 4 hours while symptoms last

■ do not give more than 5 times in 24 hours

■ replace cap tightly to maintain child

resistance

DOSING CHART

Weight (lbs) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL

*or as directed by a doctor



Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Description

Active ingredient (in each 5 mL) Acetaminophen 160 mg

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

■ pain gets worse or lasts more than 5 days

■ 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.

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 your child is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 50570-1

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 is allergic to acetaminophen or any of the inactive ingredients in this product

Section 51727-6

Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Section 60561-8

Other information

each 5 mL contains: sodium 2 mg

■ store between 20-25°C (68-77°F)


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

- the common cold

- flu

- headache

- sore throat

- toothache

Dosage and Administration (34068-7)

Directions

Do not take more than directed.

See overdose warning

this product does not contain directions or complete warnings for adult use.

shake well before using

■ mL = milliliter

■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.

■ push air out of syringe. Insert syringe tip into the bottle opening

■ flip bottle upside down. Pull yellow part of syringe to correct dose

■ dispense liquid slowly into child’s mouth, toward inner cheek

■ repeat dose every 4 hours while symptoms last

■ do not give more than 5 times in 24 hours

■ replace cap tightly to maintain child

resistance

DOSING CHART

Weight (lbs) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL

*or as directed by a doctor



Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

■ more than 5 doses in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

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.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ pain gets worse or lasts more than 5 days

■ 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.

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 your child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 50570-1 (50570-1)

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 is allergic to acetaminophen or any of the inactive ingredients in this product

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Section 60561-8 (60561-8)

Other information

each 5 mL contains: sodium 2 mg

■ store between 20-25°C (68-77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)