MAX RELIEF JUNIOR- acetaminophen liquid

MAX relief junior by

Drug Labeling and Warnings

MAX relief junior by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Purpose

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses

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

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

SPL UNCLASSIFIED SECTION

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.

DOSAGE & 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.

INACTIVE INGREDIENT

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

QUESTIONS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAX RELIEF JUNIOR 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0045(NDC:71399-0021)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0045-1	48 in 1 BOX, UNIT-DOSE	02/28/2024
1	NDC: 17856-0045-5	7.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 17856-0045-2	120 in 1 BOX, UNIT-DOSE	02/28/2024
2	NDC: 17856-0045-6	1.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 17856-0045-3	120 in 1 BOX, UNIT-DOSE	02/28/2024
3	NDC: 17856-0045-7	2.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 17856-0045-4	120 in 1 BOX, UNIT-DOSE	02/28/2024
4	NDC: 17856-0045-8	2.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	05/14/2023

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0045)