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NDC 55154-4063-05 Acetaminophen 160 mg/5mL Details

Acetaminophen 160 mg/5mL

Acetaminophen is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 107, LLC. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 55154-4063-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	55154-4063
Product ID	55154-4063_bb9ee959-675a-4870-992d-743fc91278de
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Cardinal Health 107, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 55154-4063-05 (55154406305)

Pricing Information	N/A
NDC Package Code	55154-4063-5
Billing NDC	55154406305
Package	5 CUP, UNIT-DOSE in 1 BAG (55154-4063-5) / 10.15 mL in 1 CUP, UNIT-DOSE
Marketing Start Date	2019-11-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4ffb5fdc-4978-4a8b-a40b-247aa56c5e8d Details

Active ingredient (in each 10.15 mL)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscle 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 you take

■ more than 4000 mg in 24 hours

■ with other drugs containing acetaminophen

■ 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.

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 or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ 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.

Overdose warning: 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 for children even if you do not notice any signs or symptoms.

Directions

■ do not take more than directed (see overdose warning)

■ do not take more than 8 doses in any 24-hour period

■ dose as follows or as directed by doctor

■ take only with dosing cup provided

■ adults and children 12 years of age and older: 10.15 mL (325 mg) every 3 - 4 hours

■ children under 12 years of age: ask a doctor

Other information

■ each 10.15 mL contains: sodium 16 mg

■ store at 20 -25°C (68 -77°F)

■ do not use if foil on cup is missing or torn

Inactive ingredients

anhydrous citric acid, FD&C blue no. 1, FD& C red no. 40, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

Questions or comments?

Call 1-888-655-1505

How Supplied

Overbagged with 5 cups of 10.15 mL, NDC 55154-4063-5

Distributed by:

VistaPharm Inc.

Largo, FL 33771, USA

Distributed by:

Cardinal Health

Dublin, OH 43017

VP2511

10/2019

Principal Display Panel

Acetaminophen Oral Solution, USP

325 mg per 10.15 mL (160 mg/ 5mL)

5 Cups

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-4063(NDC:66689-055)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55154-4063-5	5 in 1 BAG	11/22/2019
1		10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/22/2019

Labeler - Cardinal Health 107, LLC (118546603)

Revised: 9/2022

Document Id: bb9ee959-675a-4870-992d-743fc91278de

Set id: 4ffb5fdc-4978-4a8b-a40b-247aa56c5e8d

Version: 2

Effective Time: 20220930