Acetaminophen Oral Solution Usp
6ec12573-03d6-40c1-9945-d345b401e062
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
ACETAMINOPHEN 160 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
ACETAMINOPHEN 160 mg
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
Section 42229-5
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
Section 50565-1
Keep out of reach of children.
Section 50568-5
Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.
Section 50569-3
Ask a doctor before use if the user has liver disease
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
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 |
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
Manufactured By:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R10/20
Active Ingredient
ACETAMINOPHEN160 mg
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:
NDC 0121-0657-05: 5 mL unit dose cup
NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1314-11: 10.15 mL unit dose cup
NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1971-21: 20.3 mL unit dose cup
NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.
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.
Stop Use and Ask A Doctor If
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
Principal Display Panel 5 Ml Cup
Delivers 5 mL
NDC 0121-0657-05
Acetaminophen Oral Solution USP
160 mg/5 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657051020
Principal Display Panel 10 Ml Cup
Delivers 10.15 mL
NDC 0121-1314-11
Acetaminophen Oral Solution USP
325 mg/10.15 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657111020
Principal Display Panel 20.3 Ml Cup
Delivers 20.3 mL
NDC 0121-1971-21
Acetaminophen Oral Solution USP
650 mg/20.3 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657211020
Structured Label Content
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
Section 42229-5 (42229-5)
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
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.
Section 50569-3 (50569-3)
Ask a doctor before use if the user has liver disease
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Purpose
Pain reliever/fever reducer
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 |
Do Not Use (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
Manufactured By: (MANUFACTURED BY:)
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R10/20
Active Ingredient (Active ingredient)
ACETAMINOPHEN160 mg
Other Information (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:
NDC 0121-0657-05: 5 mL unit dose cup
NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1314-11: 10.15 mL unit dose cup
NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1971-21: 20.3 mL unit dose cup
NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.
Inactive Ingredients: (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? (Questions or comments?)
Call 1-800-845-8210. You may also report serious side effects to this phone number.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
Principal Display Panel 5 Ml Cup (PRINCIPAL DISPLAY PANEL - 5 mL Cup)
Delivers 5 mL
NDC 0121-0657-05
Acetaminophen Oral Solution USP
160 mg/5 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657051020
Principal Display Panel 10 Ml Cup (PRINCIPAL DISPLAY PANEL - 10 mL Cup)
Delivers 10.15 mL
NDC 0121-1314-11
Acetaminophen Oral Solution USP
325 mg/10.15 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657111020
Principal Display Panel 20.3 Ml Cup (PRINCIPAL DISPLAY PANEL - 20.3 mL Cup)
Delivers 20.3 mL
NDC 0121-1971-21
Acetaminophen Oral Solution USP
650 mg/20.3 mL
ALCOHOL FREE
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F0657211020
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Source: dailymed · Ingested: 2026-02-15T12:03:24.866265 · Updated: 2026-03-14T23:03:28.306097