Acetaminophen by PAI Holdings, LLC dba PAI Pharma / PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC dba PAI Pharma, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 10.15 mL)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains due to

• headache
• muscular aches
• backache
• sore throat
• flu
• the common cold
• toothache
• premenstrual and menstrual cramps

for the minor pain from arthritis
and to reduce fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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.

Sore throat warning: If sore throat is severe, persists for 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
• if you are allergic to aetaminophen or any of the inactive ingredients of this product
  
  

ASK DOCTOR

Ask a doctor before use if the user
     has liver disease
     is a child with pain of arthritis

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• adult's pain gets worse or lasts more than 10 days
• child's pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• any new symptoms appear

PREGNANCY OR BREAST FEEDING

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

Keep out of reach of children.

OVERDOSAGE

Overdose warning:  Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.  (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• dose product from the single dose cup the product is packaged in
• mL=milliliter

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours; not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours; not to exceed 5 doses in a 24-hour period
children under 6 years of age	consult a doctor

Other information

■ Each 10.15 mL contains: sodium 12 mg

■ store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Distributed by:

PAI Pharma
Greenville,SC 29605
www.paipharma.com
R05/25

PRINCIPAL DISPLAY PANEL - 10.15 mL Cup

Delivers 10.15 mL

NDC: 0121-2094-11

Acetaminophen
Oral Solution USP
325 mg/10.15 mL

Pain Reliever/Fever Reducer

Alcohol Free/Dye Free/Sugar Free
Grape Flavored

Package Not Child-Resistant

Dist. by: PAI Pharma
GREENVILLE, SC 29605
See insert for drug facts

 

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-2094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10.15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-2094-00	10 in 1 CASE	12/09/2025
1		10 in 1 TRAY
1	NDC: 0121-2094-11	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/09/2025

Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	manufacture(0121-2094)