MEJORALITO- acetaminophen suspension 
OPMX Chula Vista

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Mejoralito

Active Ingredient(in each 5 mL) Purpose

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

Pain Reliever & Fever Reducer

Uses

temporarily:

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes takes


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 (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.

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 recommened dose (see overdose warning)

Stop use and ask a doctor if

These could be signs of a serious condition

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

Directions

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

Inactive ingredients

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?

Call toll free 619-600-5632

Monday through Fnday 9AM - 5PM EST

PRINCIPAL DISPLAY PANEL

NDC 69729-068-04 Temperal-ito

Children Fever Mejoralito 4 floz

MEJORALITO 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-068
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-068-041 in 1 CARTON06/02/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/02/2023
Labeler - OPMX Chula Vista (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Medical, LLC078774921manufacture(69729-068) , pack(69729-068) , label(69729-068)

Revised: 4/2024
Document Id: 155ba6fe-7c58-c9bb-e063-6394a90a352b
Set id: fd2ecde0-296e-060f-e053-6294a90afd98
Version: 6
Effective Time: 20240405
 
OPMX Chula Vista