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

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen liquid 
Safecor Health, LLC

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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:

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

Warnings:

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

• more than 5 doses is taken in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday 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

• 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

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

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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.

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:

• Do not take more than directed
• Find dose in chart below
• If possible, use weight to dose, otherwise use age
• Dosage may be repeated every 4 hours, or as directed by a doctor
• Do not give more than 5 doses in 24 hours

Weight (lbs)	Under 24	24-35	36-47	48-59	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 Physician	5 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:

• Store at room temperature 15°C- 30°C (59°F-86°F)
• Protect from freezing
• Protect from light
• Aspirin Free
• Alcohol Free
• TAMPER-EVIDENT: Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe.
• For more info call 1-800-447-1006

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)

ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-401(NDC: 54859-809)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 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: 48433-401-25	25 in 1 BOX	11/01/2022	10/01/2024
1	NDC: 48433-401-05	5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M343	11/01/2022	10/01/2024

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		078805287	repack(48433-401) , relabel(48433-401)

Revised: 10/2024

Document Id: 2ea7a853-6c44-4717-b75b-4086596d8fd4

34390-5

Set id: eab49198-9e9f-4d2e-b029-9e79bd14de0a

Version: 2

Effective Time: 20241002