ACETAMINOPHEN- acetaminophen oral solution solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Belleview Biosciences LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:

■ Dosage may be repeated every 4 hours, or as directed by doctor

■ Do not exceed recommended dose.

■ Find dose in chart below ■ If possible, use weight to dose, otherwise use age

Dosage

Weight (lbs)	Under 24	24-35	36-47	48-59	60-71	72-95	Over 95
Age (years)	Under 2	2 to 3	4 to5	6 to 8	9 to 10	11	12 to Adult
Dosage Teaspoonful (tsp)	consult a doctor	1 tsp (5 mL)	1 1/2 tsp (7.5 mL)	2 tsp (10mL)	2 1/2 tsp (12.5 mL)	3 tsp (15 mL)	4 tsp (20mL)

WARNINGS

Warnings:Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if.

■ adults take more than 6 doses in 24 hours, which is the maximum daily amount

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen (prescription or nonprescription)

■ adult has 3 or more alcoholic drinks while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may

include: ■ skin reddening ■ blisters ■rash

If skin reaction occurs, stop use and seek medical help right away

Do not use with any other product containing acetaminophen (prescription or

nonprescription), this will provide more than the recommended dose (overdose)

of acetaminophen and could cause serious health concerns. If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE

Ask a doctor before use if you have a liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask doctor if: ■ pain gets worse or lasts more than 10 days in adults

■ pain gets worse or lasts more than 5 days in children under 12 years

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

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

INACTIVE INGREDIENT

Inactive ingredients:Citric Acid, Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol,

Sucralose

INDICATIONS & USAGE

Uses:Temporarily relieves minor aches and pains due to: ■ headache

■ backache ■ muscular aches ■ minor pain of arthritis ■ the common cold

■ toothache ■ premenstrual and menstrual cramps

Temporarily reduces fever.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Purpose:

Pain reliever/Fever reducer

ACTIVE INGREDIENT

Active Ingredient(in each 5 mL tsp)

Acetaminophen,160mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen oral solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84447-104
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
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84447-104-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2024
2	NDC: 84447-104-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2024
3	NDC: 84447-104-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2024
4	NDC: 84447-104-01	200000 mL in 1 DRUM; Type 0: Not a Combination Product	07/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/20/2024

Labeler - Belleview Biosciences LLC (131968803)

Establishment
Name	Address	ID/FEI	Business Operations
Belleview Biosciences LLC		131968803	label(84447-104) , manufacture(84447-104) , analysis(84447-104) , pack(84447-104)