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
- American Health Packaging
- Effective date
- 2024-10-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:27:44
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure11 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 under 6 years of age consult a doctor
Storage and handling
Each 10.15 mL contains: sodium 4 mg store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] protect from light a red, cherry flavored solution supplied in the following oral dosage forms: 10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56
Contacts and useful links#
Label contents#
Full prescribing information#
Purpose
Pain reliever/fever reducer
Active ingredient(in each 10.15 mL cup)
Acetaminophen 325 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
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount
- child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
- 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning 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.
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 under 6 years of age | consult a doctor |
Other information
- Each 10.15 mL contains: sodium 4 mg
- store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
- protect from light
- a red, cherry flavored solution supplied in the following oral dosage forms:
10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56
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.
SPL UNCLASSIFIED SECTION
DO NOT USE IF SEAL IS BROKEN.
Distributed by:
American Health Packaging
Columbus, OH 43217
R03/23
Principal Display Panel – Tray Label
Case NDC 60687-751-56/Cup NDC 60687-751-42
ACETAMINOPHEN
ORAL SOLUTION USP
325 mg/10.15 mL
ALCOHOL FREE
Each 10.15 mL contains:
Acetaminophen 325 mg
USUAL DOSAGE: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
For Institutional Use Only.
T0657C110323 R03/23
Principal Display Panel – Cup – 325 mg / 10.15 mL
NDC 60687- 751-42
ACETAMINOPHEN
ORAL SOLUTION USP
Pain Reliever/Fever Reducer
325 mg/10.15 mL
ALCOHOL FREE
Delivers 10.15 mL
Protect from light.
See packaging Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0657C110323
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 2 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 2 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 2 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 2 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60687-751-42 | Acetaminophen | 10.15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10.15 | 2 | |
| 60687-751-48 | Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | 2 | |
| 60687-751-56 | Acetaminophen | 10 in 1 CASE | SOLUTION | 10 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60687-751-42 | ML - Milliliter | 60687-751 | 999f2947-b110-45a0-b6f9-a44405c7e434 | 1 | 2023-08-08 |
| 60687-751-56 | ML - Milliliter | 60687-751 | 9d4e7a56-e5e2-4933-953d-327313980cc7 | 1 | 2023-08-08 |
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, UNSPECIFIED FORM
- SORBITOL
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60687-751 | 60687-751-42, 60687-751-48, 60687-751-56 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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 | American Health Packaging | 0d6553bd-3e18-4624-a83a-899bcafb3272 | 2024-10-21 | Warnings | 60687-751-56 60687-751-42 60687-751-48 60687-751 60687075148 60687075142 60687075156 24ffd617-a9f8-f406-e063-6394a90a6b5c 0d6553bd-3e18-4624-a83a-899bcafb3272 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.