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
Uses
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
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 | over 95 |
| Age (years) | under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| 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) | 4 tsp (20 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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 3 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 3 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 3 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 3 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 3 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 3 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 3 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-7014-1 | Children Acetaminophen Oral Solution | 5 mL in 1 CUP, UNIT-DOSE | LIQUID | 5 | 3 | |
| 17856-7014-1 | Children Acetaminophen Oral Solution | 72 in 1 BOX, UNIT-DOSE | LIQUID | 72 | 3 | |
| 17856-7014-2 | Children Acetaminophen Oral Solution | 48 in 1 BOX, UNIT-DOSE | LIQUID | 48 | 3 | |
| 17856-7014-2 | Children Acetaminophen Oral Solution | 5 mL in 1 SYRINGE | LIQUID | 5 | 3 | |
| 17856-7014-3 | Children Acetaminophen Oral Solution | 50 in 1 BOX, UNIT-DOSE | LIQUID | 50 | 3 | |
| 17856-7014-3 | Children Acetaminophen Oral Solution | 15.6 mL in 1 CUP, UNIT-DOSE | LIQUID | 15.6 | 3 | |
| 17856-7014-4 | Children Acetaminophen Oral Solution | 2.5 mL in 1 SYRINGE | LIQUID | 2.5 | 3 | |
| 17856-7014-4 | Children Acetaminophen Oral Solution | 120 in 1 BOX, UNIT-DOSE | LIQUID | 120 | 3 | |
| 17856-7014-5 | Children Acetaminophen Oral Solution | 1.25 mL in 1 SYRINGE | LIQUID | 1.25 | 3 | |
| 17856-7014-5 | Children Acetaminophen Oral Solution | 120 in 1 BOX, UNIT-DOSE | LIQUID | 120 | 3 | |
| 17856-7014-6 | Children Acetaminophen Oral Solution | 120 in 1 BOX, UNIT-DOSE | LIQUID | 120 | 3 | |
| 17856-7014-6 | Children Acetaminophen Oral Solution | 2.5 mL in 1 SYRINGE | LIQUID | 2.5 | 3 | |
| 17856-7014-7 | Children Acetaminophen Oral Solution | 20.31 mL in 1 CUP, UNIT-DOSE | LIQUID | 20.31 | 3 | |
| 17856-7014-7 | Children Acetaminophen Oral Solution | 50 in 1 BOX, UNIT-DOSE | LIQUID | 50 | 3 | |
| 17856-7014-8 | Children Acetaminophen Oral Solution | 31.2 mL in 1 CUP, UNIT-DOSE | LIQUID | 31.2 | 3 | |
| 17856-7014-8 | Children Acetaminophen Oral Solution | 50 in 1 BOX, UNIT-DOSE | LIQUID | 50 | 3 | |
| 17856-7014-9 | Children Acetaminophen Oral Solution | 72 in 1 BOX, UNIT-DOSE | LIQUID | 72 | 3 | |
| 17856-7014-9 | Children Acetaminophen Oral Solution | 10.15 mL in 1 CUP, UNIT-DOSE | LIQUID | 10.15 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-7014 | CHILDREN ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [ATLANTIC BIOLOGICALS CORP.] | 3 | Legacy NDC, 18 package rows | 20240420_bda0d08a-042d-4430-bd88-1a44f607b71c.zip |
| 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 |
|---|---|
| 17856-7014 | 17856-7014-1, 17856-7014-2, 17856-7014-3, 17856-7014-4, 17856-7014-5, 17856-7014-6, 17856-7014-7, 17856-7014-8, 17856-7014-9 |
| 0904-7014 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| 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 |
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 |
| 62d78fb0-c1bb-4757-bb18-a899856dd6b0 | bda0d08a-042d-4430-bd88-1a44f607b71c | 2024-04-19 | Warnings | 62d78fb0-c1bb-4757-bb18-a899856dd6b0 bda0d08a-042d-4430-bd88-1a44f607b71c |
Adverse event summaries are temporarily unavailable. Other product information remains available.