Active Ingredient
Active ingredient (in each 5 mL)
- Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Desenfriol-ito Plus (NDC 69729-835). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each 5 mL)
temporarily
Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
liver disease
taking the blood thinning drug warfarin.
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition
Keep out of reach of children
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.
| 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
store at room temperature 20°-25°C (68°-77°F). Protect from Freezing. Protect from Light.
anhydrous citric acid, cherry flavor, glycerin, microcrystalline cellulose and sodium carboxymethylcellulose, potassium sorbate, purified water, sorbitol, sucralose, sucrose, xanthan gum.
Call toll free 619-600-5632 Monday through Friday 9 AM - 5PM EST
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
Made for:
RRX
San Diego, CA
MADE IN INDIA
NDC 69729-024-02
SEE NEW DIRECTIONS AND WARNINGS
PENTREXCILINA®
Fever Infant
ACETAMINOPHEN 160 mg / 5mL
Oral suspension
Pain Reliever & Fever Reducer
Safe & Effective for:
2-3 years
Dye Free
Paraben Free
Cherry flavor
2fl oz (60 mL)
Fiebre Infantil
ACETAMINOPHEN 160 mg / 5mL
Suspension Oral
Rapido alivio contra Fiebre y Dolor
Uso infantil Seguro
2-3 años
Libre de Colorantes
Libre de Parabenos
Sabor Cereza
2fl oz (60 mL)
* Please review the disclaimer below.