Indications and 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
Acetaminophen Oral Solution USP Alcohol Free
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Effective date
- 2024-08-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 15
- Source
- full-release
- Hydrated at
- 2026-06-01 00:17:07
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections
Dosage and administration
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...
Storage and handling
■ 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...
Contacts and useful links#
Websitewww.paipharma.com
www.paipharma.com
www.paipharma.comLabel contents#
Full prescribing information#
Active ingredient (in each 5 mL teaspoonful)
ACETAMINOPHEN160 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
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
SPL UNCLASSIFIED SECTION
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:
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.
MANUFACTURED BY:
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 15 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 15 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 15 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 15 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 15 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 15 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 15 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0657-00 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 15 | |
| 0121-0657-00 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 15 | |
| 0121-0657-05 | Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 15 | |
| 0121-0657-11 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 15 | |
| 0121-0657-11 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 15 | |
| 0121-0657-21 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 15 | |
| 0121-0657-21 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 15 | |
| 0121-1314-00 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 15 | |
| 0121-1314-00 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 15 | |
| 0121-1314-11 | Acetaminophen | 10.15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10.15 | 15 | |
| 0121-1971-00 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 15 | |
| 0121-1971-00 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 15 | |
| 0121-1971-21 | Acetaminophen | 20.3 mL in 1 CUP, UNIT-DOSE | SOLUTION | 20.3 | 15 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0121-0657 | ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 15 | Current NDC, Legacy NDC, 7 package rows | 20240814_6ec12573-03d6-40c1-9945-d345b401e062.zip |
| 0121-1314 | ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 15 | Current NDC, Legacy NDC, 3 package rows | 20240814_6ec12573-03d6-40c1-9945-d345b401e062.zip |
| 0121-1971 | ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 15 | Current NDC, Legacy NDC, 3 package rows | 20240814_6ec12573-03d6-40c1-9945-d345b401e062.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0657-00 | ML - Milliliter | 0121-0657 | e1717ddd-2220-4c37-bf4c-358cc59233d5 | 1 | 2017-03-06 |
| 0121-0657-05 | ML - Milliliter | 0121-0657 | 8ed88d7b-7da9-4476-8acb-44b7546ea729 | 1 | 2013-02-13 |
| 0121-0657-11 | ML - Milliliter | 0121-0657 | a7c14538-cd3f-460a-9934-c44d6cfa1d56 | 1 | 2013-02-13 |
| 0121-0657-21 | ML - Milliliter | 0121-0657 | da514a8a-21cf-4316-988f-d31df443bed6 | 1 | 2013-02-13 |
| 0121-1314-00 | ML - Milliliter | 0121-1314 | aa8954f5-c2bd-4e7e-beb0-7a668fa55bf9 | 1 | 2017-03-06 |
| 0121-1314-11 | ML - Milliliter | 0121-1314 | ee1fa35a-f336-434b-94fd-ad7730c7e196 | 1 | 2017-03-06 |
| 0121-1971-00 | ML - Milliliter | 0121-1971 | 0810fe27-830b-41ad-af96-53d88d40b4a8 | 1 | 2017-03-06 |
| 0121-1971-21 | ML - Milliliter | 0121-1971 | 91884f5f-dfff-4883-ad2e-d5461d422e40 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SORBITOL
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-0657 | 0121-0657-05, 0121-0657-00, 0121-0657-11, 0121-0657-21 |
| 0121-1314 | 0121-1314-11, 0121-1314-00 |
| 0121-1971 | 0121-1971-21, 0121-1971-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 6ec12573-03d6-40c1-9945-d345b401e062 | 2024-08-12 | Warnings | 0121-1314-00 0121-0657-05 0121-1971-00 0121-0657-21 0121-1314-11 0121-1971-21 0121-0657-00 0121-0657-11 0121-1971 0121-1314 0121-0657 00121065721 00121065705 00121197121 00121131411 00121131400 00121065700 00121197100 00121065711 1f8166c0-62db-10f8-e063-6394a90a86cf 6ec12573-03d6-40c1-9945-d345b401e062 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.