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:
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- headache
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- muscular aches
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- backache
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- minor pain of arthritis
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- the common cold
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- toothache
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- premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
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- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription).
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- if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- for more than 10 days for pain unless directed by a doctor
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- for more than 3 days for fever unless directed by a doctor
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- 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
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- symptoms do not improve
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- new symptoms occur
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- 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 |
children 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours |
children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours |
children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours |
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
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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.