Acetaminophen Oral Solution
Acetaminophen Oral Solution USP Alcohol Free
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Acetaminophen Oral Solution Uses
- Warnings
- Directions
- Acetaminophen Oral Solution Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient (in each 5 mL teaspoonful)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Acetaminophen Oral Solution 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
- adult has 3 or more alcoholic drinks everyday while using this product
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.
- 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 thinning drug warfarin.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults and children
- 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.
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 |
Acetaminophen Oral Solution Other information
- sodium content: 2 mg/5 mL
- 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:
NDC 0121-0657-05 (unit dose cups of 5 mL, 10 × 10's), NDC 0121-0657-11 (unit dose cups of 10.15 mL, 10 × 10's), and NDC 0121-0657-21 (unit dose cups of 20.3 mL, 10 × 10's).
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.
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com
Repackaged by Cardinal Health
Zanesville, OH 43701
R04/10
PRINCIPAL DISPLAY PANEL
ACETAMINOPHEN ORAL SOLUTION USP
325 mg/ 10.15 mL
5 - 10.15 mL CUPS
Acetaminophen Oral SolutionAcetaminophen LIQUID
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