FDA.reportPublic FDA data

Dolex

Manufacturer
Pharmadel LLC
Effective date
2024-03-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:28

Label at a glance#

ProductDolex Children Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pain due to: a cold headache sore throat toothache and to reduce fever

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 use the dose that corresponds to your child's age Age (years) Dose (mL)* under 2 consult a doctor 2 to under 4 5 mL 4 to under 5 7.5 mL 6 to under 8 10 mL 9 to under 10 12.5 mL 11 to under 12 15 mL *Dose may be repeated every 4 hours wh...

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each 5 mL)Purpose
Acetaminophen 160 mgPain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain due to:

  • a cold
  • headache
  • sore throat
  • toothache
  • and to reduce fever

Warnings

WARNINGS SECTION

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

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • redness or swelling is present

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

OVERDOSAGE SECTION

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • use the dose that corresponds to your child's age
Age (years)Dose (mL)*
under 2consult a doctor
2 to under 45 mL
4 to under 5

7.5 mL

6 to under 8 10 mL
9 to under 1012.5 mL
11 to under 1215 mL

*Dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.

Other information

OTHER SAFETY INFORMATION

  • each 5 mL contains: sodium 3 mg
  • store between 68-77° F (20-25° C)
  • do not refrigerate
  • keep carton for full directions for use

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous 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

Questions?

OTC - QUESTIONS SECTION

+1-866-359-3478 (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:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC.

New Castle, DE 19720

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP DCPFPDP DCPF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-026-04DolexChildren Pain and Fever1 in 1 BOXSUSPENSION13
55758-026-04DolexChildren Pain and Fever118 mL in 1 BOTTLESUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-026DOLEX CHILDREN PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [PHARMADEL LLC]3Current NDC, 2 package rows20240307_f9158463-aeb1-5de0-e053-6294a90a748b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-02655758-026-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
GLYCERINPDC6A3C0OXIACT
BUTYLPARABEN3QPI1U3FV8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
ndc (package): 55758-026-04
ndc (product): 55758-026
ndc11 (package): 55758002604
spl id: 12dcac76-11bc-2c3b-e063-6394a90a35c6
spl set id: f9158463-aeb1-5de0-e053-6294a90a748b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.