PUREGEN LABS ACETAMINOPHEN- acetaminophen liquid

Puregen Labs Acetaminophen by

Drug Labeling and Warnings

Puregen Labs 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

Acetaminophen 500 mg

PURPOSE

Pain Relever/Fever Reducer

INDICATIONS & USAGE

USES

• temporarily relieves minor aches and pains due to
• headache
• toothache
• muscular aches
• the common cold
• backache
• minor pain from arthritis
• premenstrual and menstrual cramps
• temporarily reduces fever

WARNINGS

Warnings

Liver Warning: This product contains acetaminophen. The maxium daily dose of this product is 90 mL in 24 hours. Severe liver damage may occur if you take

• more than 120 ml (4,000 mg of acetaminophen) in 24 hours
• with other drusg containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause 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 doctor or pharmacist
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warafin

When using this product: Do not exceed recommeneded dose.

STOP USE

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever get 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• do not take more than directed

• 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 tablespoonfuls in 24 hours
• Children under 12 years: do not use

INACTIVE INGREDIENT

Inactive ingredients: artificail 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? 1-800-630-8895

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUREGEN LABS ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-001
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
SODIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-001-13	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/01/2025

Labeler - Advanced Rx LLC (042795108)