Active Ingredients
Active ingredients (in each tablet)
- Acetaminophen 500 mg
- Chlorpheniramine Maleate 4 mg
- Phenylephrine HCl 10 mg
Desenfriol D Tablet
FDA Label NDC 69729-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Desenfriol D (NDC 69729-829). 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 ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or a pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- Pain reliever / Fever reducer
- Antihistamine
- Nasal decongestant
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies
- headache
- sinus congestion & pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
- bloating
- water-weight gain
- headache
- backache
- muscle aches
- fatigue
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 tablets in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Skin reddening
- blisters
- rash.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- 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 you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- to make a child sleepy
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or A Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- Do not take more than directed - See Overdose warning
- Swallow whole; do not crush, chew or dissolve
- Do not exceed 6 tablets per 24 hours
| Adults and children 12 years of age & over | 1 tablet with water every 4-6 hours as needed |
| Children 4 to 12 years of age | Ask a doctor |
| Children under 4 years of age | Do not use |
Other Information
- Store at room temperature 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
- Avoid excessive heat and humidity
- Tamper Evident: do not use if package or blister unit is open or shows any sign of tampering
Questions Or Comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
Inactive Ingredients
Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc.
Distributed By
Made for:
RRX San Diego, CA
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
Principal Display Panel
NDC 69729-829-30
DESENFRIOL
Acetaminophen 500 mg Pain Reliever / Fever Reducer - Chlorpheniramine Maleate 4mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
To relieve common symptoms of
Cold & Allergy such as:
Ayuda a Aliviar los Síntomas de Gripe y Alergias como:
Cold/Allergy
Relief
30 Tablets
Headache/Dolor de cabeza
Nasal Congestion / Congestion Nasal
Sneezing / Estornudos
Itchy, Watery eyes and Runny Nose
Comezon, Ojos Llorosos y flujo Nasal
* Please review the disclaimer below.
