OTC - ACTIVE INGREDIENT SECTION
Active ingredient (per 5 mL teaspoonful)
Acetaminophen 160 mg
Active ingredient (per 5 mL teaspoonful)
Acetaminophen 160 mg
Purpose
Pain Reliever/Fever Reducer
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor before use if your child hasliver disease.
Ask a doctor before use if your child istaking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
Uses
If pregnant or breast-feeding, ask a health professional before use
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.
Directions
| 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 ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Changed Uses to:
temporarily relieves minor aches and pains due to
Removed 12 years to adult from dosage
| 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 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Data Matrix | (01)00383939001028(21)02485001(10)024850(17)260322 | GTIN-14: 00383939001028 GTIN-12: 383939001028 UPC-A: 383939001028 EAN-13: 0383939001028 GTIN storage (14 digits): 00383939001028 | Child Acetaminophen 001002 (002).jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83939-0010-1 | Children Acetaminophen Oral Solution | 1 mL in 1 CUP, UNIT-DOSE | LIQUID | 1 | 1 | |
| 83939-0010-2 | Children Acetaminophen Oral Solution | 10 in 1 BOX, UNIT-DOSE | LIQUID | 10 | 1 | |
| 83939-0010-2 | Children Acetaminophen Oral Solution | 1 mL in 1 CUP, UNIT-DOSE | LIQUID | 1 | 1 | |
| 83939-0010-3 | Children Acetaminophen Oral Solution | 1 mL in 1 CUP, UNIT-DOSE | LIQUID | 1 | 1 | |
| 83939-0010-3 | Children Acetaminophen Oral Solution | 40 in 1 BOX, UNIT-DOSE | LIQUID | 40 | 1 | |
| 83939-0010-4 | Children Acetaminophen Oral Solution | 50 in 1 BOX, UNIT-DOSE | LIQUID | 50 | 1 | |
| 83939-0010-4 | Children Acetaminophen Oral Solution | 1 mL in 1 CUP, UNIT-DOSE | LIQUID | 1 | 1 | |
| 83939-0010-5 | Children Acetaminophen Oral Solution | 1 mL in 1 CUP, UNIT-DOSE | LIQUID | 1 | 1 | |
| 83939-0010-5 | Children Acetaminophen Oral Solution | 100 in 1 BOX, UNIT-DOSE | LIQUID | 100 | 1 |
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83939-0010 | 83939-0010-1, 83939-0010-2, 83939-0010-3, 83939-0010-4, 83939-0010-5 |
| 0904-7014 |
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 |
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 | VERITYRX. LLC | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 2025-11-02 | Warnings | 83939-0010-1 83939-0010-3 83939-0010-4 83939-0010-5 83939-0010-2 83939-0010 83939001004 83939001002 83939001001 83939001003 83939001005 42a17f6b-4652-cb84-e063-6294a90ae477 42a17f54-7851-84fb-e063-6394a90a9ec1 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | MAJOR PHARMACEUTICALS | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 2025-06-09 | Warnings | 0904-7014 |
Adverse event summaries are temporarily unavailable. Other product information remains available.