Indications and uses
temporarily reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Dolex Childrens Pain and Fever
- Manufacturer
- Pharmadel LLC
- Effective date
- 2022-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:42:14
Label at a glance#
ProductDolex Childrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use shake well before using use only enclosed dosing cup. Do not use any other dosing device 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...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient & Purpose
OTC - PURPOSE SECTION
| Active ingredient (in each 5 mL = 1 teaspoonful) | Purpose |
| Acetaminophen 160 mg | Pain reliever/ fever reducer |
Uses
temporarily
- reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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 throat 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 acetaminophen or any other of the inactive ingredients in this product
Ask a doctor before use if your child has
liver disease.
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 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.
Keep out of reach of children.
Keep out of reach of children.
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 at 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.
Directions
- this product does not contain directions or complete warnings for adult use
- shake well before using
- use only enclosed dosing cup. Do not use any other dosing device
- 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 | undere 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL (1 tsp) |
| 36-47 | 45-5 years | 7.5 mL (1 1/2 tsp) |
| 48-59 | 6-8 years | 10 mL (2 tsps) |
| 60-71 | 9-10 years | 12.5 mL (2 1/2 tsps) |
| 72-95 | 11 years | 15 mL (3 tsps) |
*or as directed by a doctor
Other information
- each 5 mL (1 tsp) contains: sodium 2 mg
- store between 68-77° F (20-25° C)
- do not refrigerate
- keep carton for full directions for use
Inactive ingredients
anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions?
1-877-798-5944 (9 AM - 5 PM EST) or pharmadel.com
** This product is not manufactured or distributed by Mcneil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension.
Distributed by:
PHARMADEL LLC.
New Castle, DE 19720
Principal Display Panel
4 FL OZ (118 mL)
Ages 2 to 11
Products#
Every source-derived product name is available through these pages.
- Dolex Childrens Pain and Fever
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- HIGH FRUCTOSE CORN SYRUP
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-330 | 55758-330-04 |
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 |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 |
|---|---|---|---|---|---|---|
| 054646b0-81a4-0b1a-e063-6294a90a4e76 | ef58a21a-a4c9-4a2c-e053-2a95a90adde6 | 2023-09-13 | Warnings | ef58a21a-a4c9-4a2c-e053-2a95a90adde6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.