Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN
Labeler / manufacturerOPMX
RouteORAL
Drug classDrug class not supplied in source label
Product NDC69729-823
Label effective date2026-09-03
Official product label reference
Mejoralito — OPMX
This page contains 16 source sections for ACETAMINOPHEN, oral route. Label set 5a963a92-e29d-05ba-e063-6394a90a3a47, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Purpose
Purpose Pain reliever/ fever reducer
Dosage and administration — label text
Directions this product does not contain directions or complete warnings for adult use, shake well before using mL= mililiter find right dose on chart below, if possible, use weight to dose; otherwise, use age. use only the enclosed dropper designed for use with product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms lasts do not give more than 5 times in 24 hours do not give more than 5 days unless directed by doctor (see overdose warning) Weight (lbs) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 24 to 35 2 to 3 1 tsp or 5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 48 to 59 6 to 8 2 tsp or 10 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 72 to 95 11 3 tsp or 15 mL *or as directed by doctor
Table text from source:
| Weight (lbs) | Age (yrs.) | Dose (tsp or mL)
| under 24 | under 2 | ask a doctor
| 24 to 35 | 2 to 3 | 1 tsp or 5 mL
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL
| 48 to 59 | 6 to 8 | 2 tsp or 10 mL
| 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL
| 72 to 95 | 11 | 3 tsp or 15 mL
Warnings
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 blister 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 accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription 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 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 In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
Active ingredient
Active ingredient Active ingredient (in each 5 mL) Acetaminophen 160 mg
Do not use
Do not use with any other drug containing acetaminophen (prescription 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
Ask a doctor before use
Ask a doctor before use if your child has liver disease.
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
While using this medicine
When using this product do not exceed recommended dose (see overdose warning)
When to stop use and seek help
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
Child safety
Keep out of reach of children Keep out of reach of children
Overdose information
Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
Other safety information
Other information store at room temperature 20°-25°C (68°-77°F). Protect from Freezing. Protect from Light.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.