Childrens Pain and Fever
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2024-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:16
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses temporarily ■ reduces fever
■ relieves minor aches and pains due to:
■ the common cold ■ flu ■ headache ■ sore throat
■ toothache
WARNINGS SECTION
Warnings
Liver warning
This product contains acetaminophen. Severe liver
damage may occur nyour 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 throat is severe, persists for more than 2 days,
is accompanied or followed by ever, headache, rash.
nausea or vomiting, consult a doctor promptly.
OTC - DO NOT USE SECTION
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 acetaminophen or any other of
the inactive ingredients in this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child
is taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product do not exceed
recommended dose (see overdose warning)
OTC - STOP USE SECTION
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 ■ redness or swelling is present.
These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 for children even if you
do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
■ this product does not contain directions or
complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use
weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while
symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed
by a doctor.
| Weight (lb) | Age (yr) | Dose (mL or tsp)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2 - 3 years | 5 mL (1 tsp) |
| 36-47 | 4 - 5 years | 7.5 mL (1 1/2 tsp0 |
| 48-59 | 6 - 8 years | 10 mL (2 tsp) |
| 60-71 | 9 - 10 years | 12.5. mL (2 1/2 TSP) |
| 72-95 | 11 years | 15 mL (3 tsp) |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.
OTHER SAFETY INFORMATION
Other information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25ºC (68-77ºF)
■ do not refrigerate
■ Keep carton for full directions for use.
INACTIVE INGREDIENT SECTION
Inactive ingredientsanhydrous citric acid,
butylparaben, FD&C red #40. flavor, glycerin. high
fructose corn syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol.
purified water. sodium benzoate, sorbitol solution.
sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877-798-5944
Product Label
AP SAFE®
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S TYLENOL
ORAL SUSPENSION*
Children's
Pain
& Fever
Acetaminophen
Oral Suspension
Pain reliever/Fever Reducer
• Alcohol-Free
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 11
4 FL OZ (118 mL)
160 mg per 5 mL
Cherry Flavor
DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSINGThis
Product is not manufactured or distributed
by McNeil Consumer Healthcare, distributor of
Children's Tylenol®Oral Suspension.
Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken. NJ 08110
2 OZ PACKAGE
4 OZ PACKAGE
Carton
Bottle
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 3 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 3 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 3 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 3 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-525-23 | Childrens Pain and Fever | 1 in 1 CARTON | SUSPENSION | 1 | 3 | |
| 76281-525-23 | Childrens Pain and Fever | 59 mL in 1 BOTTLE | SUSPENSION | 59 | 3 | |
| 76281-525-24 | Childrens Pain and Fever | 1 in 1 CARTON | SUSPENSION | 1 | 3 | |
| 76281-525-24 | Childrens Pain and Fever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- BUTYLPARABEN
- FD&C RED NO. 40
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- CELLULOSE, MICROCRYSTALLINE
- CARBOXYMETHYLCELLULOSE SODIUM
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL SOLUTION
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-525 | 76281-525-24, 76281-525-23 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 11bf6e1b-aed9-4f8f-9f03-ea911ae9f702 | 2024-12-23 | Warnings | 76281-525-24 76281-525-23 76281-525 76281052523 76281052524 2b6a4462-18fb-457a-bb24-22418fd79c03 11bf6e1b-aed9-4f8f-9f03-ea911ae9f702 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


