PURGENLABS ACETAMINOPHEN- actaminophen liquid

PurgenLabs Acetaminophen by

Drug Labeling and Warnings

PurgenLabs Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

in each 15 mL Tablespoonful

Acetaminophen 500 mg

PURPOSE

Purpose

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains
• temporarily reduces fever

WARNINGS

Warnings

Liver Warning:This product contains acetaminophen. The maximurr
daily dose of fhis product is 6 tablespoonfuls in 24 hours.
Severe liver damage may occur if you take
more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24
hours with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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 octor or pharmacist.
if you are allergic to acetaminophen or any of the inactive
ingredients in this product

Ask a doctor before use ff rou have liver disease.
Ask a doctor before use ff you are taking the blood thinning
drug wartarin.
When using this product Do not exceed recommended dose.

STOP USE

Stop use and ask a doctor If pain gets worse or lasts more than
10 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 

DOSAGE & ADMINISTRATION

• Age: Dose
• adults and children 12 years of age and older: Take 1 to 2 Tablespoonfuls every 4 to 6 hours as needed; not more than 6 tablespoonsfuls in 24 hours
• children under 12 years: Do not use

INACTIVE INGREDIENT

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

QUESTIONS

Questions or comments? call toll free 1-800-630-8895

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURGENLABS ACETAMINOPHEN 
actaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-230
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-230-08	1 in 1 CARTON	06/01/2024
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2024

Labeler - Advanced Rx LLC (042795108)