Childrens Pain and Fever
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2021-05-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:45:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
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 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
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 fever, 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
adrug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the
inactive ingredlents 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.
When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if
- pain gets worseor 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.
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
occur • 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.
Overdose warning
Taking more than the recommended dose (overdose) may can 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
DOSAGE & ADMINISTRATION SECTION
Directions
- this product does not contain directions or complete warnings for adult use.
- shake well before using
- mL = milliter; tsp = teaspoon
- find right dose on 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 tsp) |
| 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 information
- each 5 mL (1 tsp) contains: sodium 3 mg
- store between 20°-25°C (68°-77°F)
- do not refrigerate
- Keep carton for full directions for use
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, butylparaben,
D&C # 33, FD&C Blue#1, flavor, glycerin, high fructose
corn syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol, purified water,
sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Package Labeling
CVS
Health®
Compare to the active
ingredient in Children's
Tylenol® Oral Suspension**
Fever Reducer/ Pain Reliever
Children's Pain and Fever
Acetaminophen Oral Suspension
- Alcohol-Free
- Ibuprofen Free
- Asprin Free
For ages 2 to 11
GRAPE FLAVOR
8 FL OZ (237 mL)
**This product is not manufactured or distrubuted
by McNeil Consumer Healthcare, distributor of
Children's Tylenol® Oral Suspension.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-37464
BX-126
Carton
Bottle
res
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- BUTYLPARABEN
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- CELLULOSE, MICROCRYSTALLINE
- CARBOXYMETHYLCELLULOSE SODIUM
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-328 | 76281-328-26 |
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 |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| 962739eb-33c7-4eb5-9799-a9d680239751 | ec28fea7-e4f0-45c3-8159-7756351f88f1 | 2023-12-30 | Warnings | ec28fea7-e4f0-45c3-8159-7756351f88f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

