Walgreen Dye-free Infants' Pain + Fever Drug Facts

Walgreen Dye-free Infants' Pain + Fever Drug Facts
SPL v3
SPL
SPL Set ID 1a304570-88b6-4c16-a8b4-c064bfa5d95a
Route
ORAL
Published
Effective Date 2022-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5

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 your child istaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child hasliver disease

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into 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 (lb) Age (yr) Dose (mL) **

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

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

1-866-467-2748

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
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
  • store at room temperature
  • Each 5 mL contains:sodium 2 mg
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Principal Display Panel

Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*

NDC 0363-6020-02

Dye-Free

Infants'

Pain + Fever

Acetaminophen

Oral Suspension

Pain Reliever-Fever Reducer

Free Of:

  • Dyes
  • Sugar Free
  • Ibuprofen
  • Aspirin
  • Parabens
  • High Fructose Corn Syrup

Natural Grape Flavor

No Added Alcohol



Use Only Enclosed Syringe

2FL OZ ( 60mL)

160 mg per 5 mL***

***Same as Children’s TYLENOL

*This Product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Dye-Free Infants’ Tylenol® Oral Suspension.

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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg


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)

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 your child istaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child hasliver disease

Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into 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 (lb) Age (yr) Dose (mL) **

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

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

1-866-467-2748

Liver Warning (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
Overdose Warning (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 (Other information)
  • store at room temperature
  • Each 5 mL contains:sodium 2 mg
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*

NDC 0363-6020-02

Dye-Free

Infants'

Pain + Fever

Acetaminophen

Oral Suspension

Pain Reliever-Fever Reducer

Free Of:

  • Dyes
  • Sugar Free
  • Ibuprofen
  • Aspirin
  • Parabens
  • High Fructose Corn Syrup

Natural Grape Flavor

No Added Alcohol



Use Only Enclosed Syringe

2FL OZ ( 60mL)

160 mg per 5 mL***

***Same as Children’s TYLENOL

*This Product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Dye-Free Infants’ Tylenol® Oral Suspension.

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)