Max Relief Junior

Max Relief Junior
SPL v1
SPL
SPL Set ID 44730cbd-5b98-49bd-b3b8-6fecb0ccd153
Route
ORAL
Published
Effective Date 2024-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Polyethylene Glycol 400 Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-14

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.

Soar throat warning: if sore throat is severe, persists or more than 2 days, is accompanied or followed by fever headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

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.

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.
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

  • this product does not contain direction 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
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hourswhile symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by doctor.

 Weight (lbs.)  Age (yrs.)  Dose (tsp or mL)
 under 24  under 2  ask a doctor
 24 to 35  2 to 3  1 tsp or 5 mL
 36 to 47  4 to 5  1 1/2 tsp or 7.5 mL
 48 to 59  6 to 8  2 tsp or 10 mL
 60 to 71  9 to 10  2 1/2 tsp or 12.5 mL
 72 to 95  11  3 tsp or 15 mL

Other Information store at room temperature 15o-30oC (59o-86oF). Protect from Freezing. Protect from light.

Description

Active ingredient (in each 5 mL) Acetaminophen 160 mg

Section 42229-5

Overdose warning. In case of overdose, get medical help or contact a Paoison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients: amydrous citric acid, bubble gum flavor, glycerin, polyethylene glycol400, punfied water, saccharin sodium, sodium benzoate, sodium citrate, sorbttol solution, sucralose.

Section 51945-4

Section 53413-1

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

This product is not manufactured by  or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Eixir.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

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

  • this product does not contain direction 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
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hourswhile symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by doctor.

 Weight (lbs.)  Age (yrs.)  Dose (tsp or mL)
 under 24  under 2  ask a doctor
 24 to 35  2 to 3  1 tsp or 5 mL
 36 to 47  4 to 5  1 1/2 tsp or 7.5 mL
 48 to 59  6 to 8  2 tsp or 10 mL
 60 to 71  9 to 10  2 1/2 tsp or 12.5 mL
 72 to 95  11  3 tsp or 15 mL

Other Information store at room temperature 15o-30oC (59o-86oF). Protect from Freezing. Protect from light.

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.

Soar throat warning: if sore throat is severe, persists or more than 2 days, is accompanied or followed by fever headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

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.

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.
Section 42229-5 (42229-5)

Overdose warning. In case of overdose, get medical help or contact a Paoison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: amydrous citric acid, bubble gum flavor, glycerin, polyethylene glycol400, punfied water, saccharin sodium, sodium benzoate, sodium citrate, sorbttol solution, sucralose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

This product is not manufactured by  or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Eixir.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

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)