feverall ®

feverall ®
SPL v4
SPL
SPL Set ID 8970b91b-5f3c-4764-9e23-25dcb398d0a7
Route
oral
Published
Effective Date 2023-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
anhydrous citric acid butylparaben fd&c red no. 40 glycerin high fructose corn syrup microcrystalline cellulose carboxymethylcellulose sodium, unspecified propylene glycol water sodium benzoate sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2023-06-01
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
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 below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information
  • each 5 mL contains:sodium 3 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • Keep carton for full directions for use.
Inactive Ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Description

Drug Facts

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

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

Purposes

Pain reliever/fever reducer

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
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

Taking more than the recommended dose (overdose) may cause liver damage. 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.

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.

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

Principal Display Panel 118 Ml Bottle Carton

NEW

ORAL

SUSPENSION

LIQUID

NDC 51672-5319-8

CHILDREN'S

ages 2-11 years

FeverAll ®

ACETAMINOPHEN (160 mg/5 mL)

Pain Reliever/Fever Reducer

Oral Suspension

Cherry Flavor

DOSING CUP

ENCLOSED

4 FL OZ (118 mL)

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
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 below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information (Other information)
  • each 5 mL contains:sodium 3 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • Keep carton for full directions for use.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

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

Purposes

Pain reliever/fever reducer

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
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)

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Sore Throat Warning (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.

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

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NEW

ORAL

SUSPENSION

LIQUID

NDC 51672-5319-8

CHILDREN'S

ages 2-11 years

FeverAll ®

ACETAMINOPHEN (160 mg/5 mL)

Pain Reliever/Fever Reducer

Oral Suspension

Cherry Flavor

DOSING CUP

ENCLOSED

4 FL OZ (118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:26.970577 · Updated: 2026-03-14T23:09:13.832086