Topco Associates Llc. Infants' Pain & Fever Drug Facts

Topco Associates Llc. Infants' Pain & Fever Drug Facts
SPL v8
SPL
SPL Set ID f1e940ef-3cf0-4a5c-8158-156d0e5a680d
Route
ORAL
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Calcium Sulfate, Unspecified Form Carrageenan D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Hydroxyethyl Cellulose, Unspecified Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sodium Phosphate, Tribasic

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-24
Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily:

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

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 the first dose line and then push product back into bottle.
  • •
    pull yellow part of syringe until it reaches and stays at the 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

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.

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
Other Information
  • •
    store at 20-25°C (68-77°F)
  • •
    do not use if printed bottle wrap is broken or missing
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?

1-888-423-0139

When Using This Product

do not exceed recommended dose (see overdose warning)

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.
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 even if you do not notice any signs or symptoms.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Package/label Principal Display Panel

TopCare® health

COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

infants’ Pain & Fever

ORAL SUSPENSION

ACETAMINOPHEN, 160 mg per 5 mL

PAIN RELIEVER • FEVER REDUCER

FREE FROM:

• Aspirin • Ibuprofen

• Alcohol • Parabens

Pediatrician Preferred Dosing System

Use only with enclosed syringe.

See side panel for more information.

GRAPE FLAVOR

1 FL OZ (30 mL)

For Children

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily:

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

Pain reliever/fever reducer

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.

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 the first dose line and then push product back into bottle.
  • •
    pull yellow part of syringe until it reaches and stays at the 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

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.

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
Other Information (Other information)
  • •
    store at 20-25°C (68-77°F)
  • •
    do not use if printed bottle wrap is broken or missing
Inactive Ingredients (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? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

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.
Keep Out of Reach of Children. (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 even if you do not notice any signs or symptoms.

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

Acetaminophen 160 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

infants’ Pain & Fever

ORAL SUSPENSION

ACETAMINOPHEN, 160 mg per 5 mL

PAIN RELIEVER • FEVER REDUCER

FREE FROM:

• Aspirin • Ibuprofen

• Alcohol • Parabens

Pediatrician Preferred Dosing System

Use only with enclosed syringe.

See side panel for more information.

GRAPE FLAVOR

1 FL OZ (30 mL)

For Children

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:16.203263 · Updated: 2026-03-14T23:03:15.788850