OTC - ACTIVE INGREDIENT SECTION
Active ingredient (per 5 mL teaspoonful)
Acetaminophen 160 mg
Children Acetaminophen Oral Solution
- Manufacturer
- MAJOR PHARMACEUTICALS
- Effective date
- 2025-06-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:02:41
Label at a glance#
ProductChildren Acetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure10 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Pain Reliever/Fever Reducer
WARNINGS SECTION
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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 thoat 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 your child is allergic to acetaminophe or any of the inactive indreadients in this product.
Ask a doctor before use if your child has liver disease.
Ask a doctor before use if your child is taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- 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.
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- the common cold
- temporarily reduces fever
- flu
- sore throat
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. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed
- find dose in chart below
- if possible, use weight to dose, otherwise use age
- dosage may be repeasted every 4 hours, or as directed by a doctor
- do not give more than 5 doses in 24 hours
| Weight (lbs) | under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | |
| Age (years) | under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | |
| Dosage Teaspoonful (tsp) | consult Physician | 1 tsp (5 mL) | 1 1/2 tsp (7.5 mL) | 2 tsp (10 mL) | 2 1/2 tsp (12.5 mL) | 3 tsp (15 mL) |
INACTIVE INGREDIENT SECTION
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
RECENT MAJOR CHANGES SECTION
Changed Uses to:
temporarily relieves minor aches and pains due to
- headache
- toothache
- the common cold
- temporarily reduces fever
- flu
- sore throat
Removed 12 years to adult from dosage
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 7 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 7 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 7 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 7 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 7 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 7 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 7 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-7014-16 | 2021-03-15 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-20 | 2021-03-15 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-16 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7014-16 | Children Acetaminophen Oral Solution | 473 mL in 1 BOTTLE | LIQUID | 473 | 7 | |
| 0904-7014-20 | Children Acetaminophen Oral Solution | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7014-16 | ML - Milliliter | 0904-7014 | fde87ac6-229a-4749-8cae-65366a4b0e4f | 1 | 2019-11-12 |
| 0904-7014-20 | ML - Milliliter | 0904-7014 | a0a63714-8c01-42e1-ade2-5f84780549ab | 1 | 2019-11-12 |
Products#
Every source-derived product name is available through these pages.
- Children Acetaminophen Oral Solution
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- METHYLPARABEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7014 | 0904-7014-16, 0904-7014-20 |
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 |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | MAJOR PHARMACEUTICALS | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 2025-06-09 | Warnings | 0904-7014-16 0904-7014-20 0904-7014 00904701420 00904701416 372893a0-1ef9-1c7c-e063-6294a90a6181 cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.