OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen solution
Cardinal Health 107, LLC

Active ingredient
(in each 5 mL 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:

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.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask a doctor before use if the user has liver disease

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

Stop use and ask a doctor if

symptoms do not improve
new symptoms occur
pain or fever persists or gets worse

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

Keep out of reach of children.

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)
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 4 to under 6 years of age

7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children 2 to under 4 years of age

5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children under 2 years of age

consult a doctor

Other information

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

650mg/20.3 mL unit dose cup

Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

Inactive ingredients:

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions or comments?

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

MANUFACTURED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed by:
Cardinal Health

Dublin, OH 43017

L53336121223

R10/20

Principal Display Panel

Acetaminophen Oral Solution USP

650 mg/20.3 mL

5 Cups

Bag Label
(click image for full-size original)
ACETAMINOPHEN
acetaminophen solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9449(NDC:0121-1971)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 20.3 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCROSE
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-9449-5 5 CUP, UNIT-DOSE in 1 BAG contains a CUP, UNIT-DOSE
1 20.3 mL in 1 CUP, UNIT-DOSE This package is contained within the BAG (55154-9449-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 08/01/2007
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 01/2024 Cardinal Health 107, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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