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 Solution
- Manufacturer
- Patrin Pharma, Inc.
- Effective date
- 2024-05-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:53
Label at a glance#
ProductAcetaminophen Solution
Active ingredientAcetaminophen
Label structure14 sections
Dosage and administration
Do not take more than directed (see overdose warning ) Use the following dosage guidelines when using this product 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 h...
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 Do not use if foil on cup is missing or torn
Contacts and useful links#
Websitewww.patrinpharma.com
www.patrinpharma.com
www.patrinpharma.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen 160 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
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
- an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
- a child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- taken with 3 or more alcoholic drinks every day while using this product
Allergy
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
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 his 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 you are 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
- redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, 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)
- Use the following dosage guidelines when using this product
| 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
- Do not use if foil on cup is missing or torn
Inactive Ingredients
Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sorbitol.
Questions Or Comments?
Call (800) 936-3088. You may also report serious side effects to this phone number.
How Supplied
- A red, cherry flavored solution supplied in the following oral dosage cups:
| NDC 39328-031-05: | 5 mL unit dose cup |
| NDC 39328-031-50: | Case contains 50 unit dose cups of 5 mL (39328-031-05). |
| NDC 39328-031-99: | Case contains 100 unit dose cups of 5 mL (39328-031-05). |
| NDC 39328-032-10: | 10.15 mL unit dose cup |
| NDC 39328-032-50: | Case contains 50 unit dose cups of 10.15 mL (39328-032-10). |
| NDC 39328-032-99: | Case contains 100 unit dose cups of 10.15 mL (39328-032-10). |
| NDC 39328-034-20: | 20.3 mL unit dose cup |
| NDC 39328-034-50: | Case contains 50 unit dose cups of 20.3 mL (39328-034-20). |
| NDC 39328-034-99: | Case contains 100 unit dose cups of 20.3 mL (39328-034-20). |
SPL UNCLASSIFIED SECTION
Patrin Pharma
Skokie, IL 60076www.patrinpharma.com
Rev 02.0424
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Delivers 5 mL
NDC 39328-031-05
Acetaminophen
Oral Solution USP
160 mg/5 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label
Delivers 10.15 mL
NDC 39328-032-10
Acetaminophen
Oral Solution USP
325 mg/10.15 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
Delivers 20.3 mL
NDC 39328-034-20
Acetaminophen
Oral Solution USP
650 mg/20.3 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 1 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 1 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 1 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 1 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 39328-031 | ACETAMINOPHEN SOLUTION (ACETAMINOPHEN) LIQUID [PATRIN PHARMA, INC.] | 1 | Current NDC | 20240524_52ae729b-2255-420c-8db8-cabdc2b74796.zip |
| 39328-032 | ACETAMINOPHEN SOLUTION (ACETAMINOPHEN) LIQUID [PATRIN PHARMA, INC.] | 1 | Current NDC | 20240524_52ae729b-2255-420c-8db8-cabdc2b74796.zip |
| 39328-034 | ACETAMINOPHEN SOLUTION (ACETAMINOPHEN) LIQUID [PATRIN PHARMA, INC.] | 1 | Current NDC | 20240524_52ae729b-2255-420c-8db8-cabdc2b74796.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 39328-031-05 | ML - Milliliter | 39328-031 | 0dda0490-b18a-4882-95fc-e25fb0e1a76c | 1 | 2024-06-10 |
| 39328-031-50 | ML - Milliliter | 39328-031 | 00a7b168-850d-4345-bc8d-c7e696ff8d13 | 1 | 2024-06-10 |
| 39328-031-99 | ML - Milliliter | 39328-031 | 24f69ebf-8fb1-4885-a59f-1f7618004b71 | 1 | 2024-06-10 |
| 39328-032-10 | ML - Milliliter | 39328-032 | ddf59f5b-3e07-47af-8b96-309879695101 | 1 | 2024-06-10 |
| 39328-032-50 | ML - Milliliter | 39328-032 | f9c30d1a-1068-44f7-929b-904e19d9182f | 1 | 2024-06-10 |
| 39328-032-99 | ML - Milliliter | 39328-032 | d5c3d74c-3562-4c20-86da-1075de749a5e | 1 | 2024-06-10 |
| 39328-034-20 | ML - Milliliter | 39328-034 | c39cac34-03d4-4936-b17d-da4f64c3a7a6 | 1 | 2024-06-10 |
| 39328-034-50 | ML - Milliliter | 39328-034 | 9fccac69-4547-4b65-b626-c5aff35a74c5 | 1 | 2024-06-10 |
| 39328-034-99 | ML - Milliliter | 39328-034 | 28d72649-9b55-4de8-b5ca-41c7c0145c38 | 1 | 2024-06-10 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Solution
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- Glycerin
- POLYETHYLENE GLYCOL 400
- WATER
- Saccharin sodium
- Sodium benzoate
- SODIUM CITRATE, UNSPECIFIED FORM
- Sorbitol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 39328-031 | 39328-031-05, 39328-031-50, 39328-031-99 |
| 39328-032 | 39328-032-10, 39328-032-50, 39328-032-99 |
| 39328-034 | 39328-034-20, 39328-034-50, 39328-034-99 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 Solution | ACETAMINOPHEN | Patrin Pharma, Inc. | 52ae729b-2255-420c-8db8-cabdc2b74796 | 2024-05-21 | Warnings | 39328-031-99 39328-032-99 39328-032-50 39328-031-50 39328-034-99 39328-034-20 39328-032-10 39328-034-50 39328-031-05 39328-034 39328-031 39328-032 39328003420 39328003250 39328003199 39328003210 39328003499 39328003105 39328003299 39328003450 39328003150 3fe345ab-3f0f-4111-afa2-d8d76ee1c410 52ae729b-2255-420c-8db8-cabdc2b74796 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.