FDA.reportPublic FDA data

Mejoralito

Manufacturer
OPMX Chula Vista | Seaway Pharma
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:37:38

Label at a glance#

ProductMejoralito
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

temporarily: reduces fever relieves minor aches and pains due to: sore throat the common cold flu headache toothache

Dosage and administration

this product does not contain directions or complete warnings for adult use. Shake well before using mL= millilitar find right dose on chart below, if possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last only use enclosed measuring syringe do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor Weight (lb,) Age (yrs.) Dose (mL)* U...

Storage and handling

Each teaspoon (5 mL) contains: sodium 3 mg Store between 15°-30°C (59°-86°F) Protect from freezing. Protect from light

Label contents#

Full prescribing information#

Active Ingredient(in each 5 mL) Purpose

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg............. Pain reliever/fever reducer

OTC - PURPOSE SECTION

Pain Reliever & Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • sore throat
  • the common cold
  • flu
  • headache
  • toothache

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes 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 (prescnption or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any 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.

SPL UNCLASSIFIED SECTION

When using this product do not exceed recommened dose (see overdose warning)

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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. Quick 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
  • mL= millilitar
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • only use enclosed measuring syringe
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
Weight (lb,)Age (yrs.)Dose (mL)*
Under 24Under 2Ask a doctor

24-35

2-3

5 mL
36-474-57.5 mL
48-596-810 mL
60-719-1012.5 mL
72-951115 mL

*always check with your doctor before administering medicine to your infant/child

Other information

STORAGE AND HANDLING SECTION

  • Each teaspoon (5 mL) contains: sodium 3 mg
  • Store between 15°-30°C (59°-86°F)
  • Protect from freezing. Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll free 619-600-5632

Monday through Fnday 9AM - 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-068-04 Temperal-ito

Children Fever Mejoralito 4 flozChildren Fever Mejoralito 4 floz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8
307668acetaminophen 32 MG/ML Oral SuspensionSCD8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8
307668APAP 32 MG/ML Oral SuspensionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-068-04Mejoralito1 in 1 CARTONSUSPENSION18
69729-068-04Mejoralito118 mL in 1 BOTTLESUSPENSION1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-068MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]8Current NDC, Legacy NDC, 2 package rows20241116_fd2ecde0-296e-060f-e053-6294a90afd98.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-06869729-068-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENOPMX LLC5b8a92c9-47c0-4438-a49d-b3878f7afd732025-08-29WarningsExact identifier
ndc (product): 69729-068
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
ndc (package): 69729-068-04
ndc (product): 69729-068
ndc11 (package): 69729006804
spl id: 26f5f344-a410-591c-e063-6294a90a39a0
spl set id: fd2ecde0-296e-060f-e053-6294a90afd98

Reported adverse events (FAERS/openFDA)#

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