Walgreens Acetaminophen 160mg/5 Ml Suspension - Infants Cherry Dye Free

Walgreens Acetaminophen 160mg/5 Ml Suspension - Infants Cherry Dye Free
SPL v2
SPL
SPL Set ID 0b1d88d8-56ff-9e9d-e063-6394a90a015c
Route
ORAL
Published
Effective Date 2024-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Hydroxyethyl Cellulose, Unspecified Anhydrous Citric Acid Sorbitol Solution Sucrose Carboxymethylcellulose Sodium, Unspecified Form Propylparaben Water Sodium Benzoate Sucralose Xanthan Gum Microcrystalline Cellulose Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-10

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

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 44425-7

Other information

store between 20-25°C (68-77°F)

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, 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


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

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 44425-7 (44425-7)

Other information

store between 20-25°C (68-77°F)

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, 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)