ACETAMINOPHEN- acetaminophen liquid 
Safecor Health, LLC

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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Acetaminophen Oral Liquid
Unit Dose Oral ENFit® Syringe
(160 mg / 5 mL)

Active Ingredient (per 5 mL = 1 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

Ask a doctor before use if you have

a 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 Poison 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 mL (tsp) Consult Physician5 mL (1 tsp )7.5 mL (1 1/2 tsp)10 mL (2 tsp)12.5 mL (2 1/2 tsp)15 mL (3 tsp)20 mL (4 tsp)

Other Information:

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

NDC: 48433-401-05 Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL)
NDC: 48433-401-25 Box of 25 Unit-Dose Oral ENFit® Syringes, each unit-dose syringe delivers 5 mL

For Oral Use Only.
For Institutional Use Only.
This Package Is Not Child Resistant.

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                  Rev: 07/2022 PN5727

Principal Display Panel

SAFECOR HEALTH

NDC 48433-401-05

Acetominophen Oral Liquid

160 mg / 5 mL

(Delivers 5 mL)

image description
ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-401(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:48433-401-2525 in 1 BOX11/01/2022
1NDC:48433-401-055 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2022
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287repack(48433-401) , relabel(48433-401)

Revised: 12/2022
Document Id: 178825f0-6fc4-479d-9715-a1a7036ef025
Set id: eab49198-9e9f-4d2e-b029-9e79bd14de0a
Version: 1
Effective Time: 20221228
 
Safecor Health, LLC