LIQUID ACETAMINOPHEN- acetaminophen liquid 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

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 you have liver disease.

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

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

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

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

 Weight (lbs) under 24 24-35 36-4748-59  60-71 72-95 over 95
Age (years)  under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
Dosage Teaspoonful (tsp)  consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

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

acetaminophen

LIQUID ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-809
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-809-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/01/2019
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 7/2022
Document Id: bc82b2f0-d6ab-41ab-8e64-2f7c4a955ba4
Set id: a7dbd4c0-53eb-4368-917b-1432c09ce6b4
Version: 2
Effective Time: 20220710
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION