Drug Facts
Active Ingredient (in each tablet)
- Acetaminophen 500mg
- Caffeine 65 mg
Doloneuro-tropas Tablet, Film Coated
FDA Label NDC 69729-795
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 Doloneuro-tropas (NDC 69729-795). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use, ask a doctor or pharmacist if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- Pain reliever
- Pain reliever aid
Uses
- temporarily relief minor aches and pains due to:
- headache
- muscular aches
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing metications, foods, or beverages while taking this product because too much cafeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do Not Use
- with anyother drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
Ask A Doctor Before Use
if you have liver disease
Ask A Doctor Or Pharmacist If
you are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- any new symptoms appear
- symptoms do not get better or worsen
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- do not exceed recommended dosage.
- adults and children 12 years and over: take 2 tablets every 6 hours;
do not take more than 6 tablets in 24 hours - children under 12 years: ask a doctor
Other Information
- store at controlled room temperatur 20° -25°C (68° -77°F)
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystaline cellulose, polyethylene glycol, pregelatinized starch, polyvinyl pyrolidone, stearic acid, tale, titanium dioxide
Questions Or Coments?
Call for free 619-600-5632 Monday through Friday 9AM -5PM EST
PLEASE REFER TO LEAFLET FOR INSTRUCTION IN SPANISH.
CONSULTE EL FOLLETO PARA LAS INTRUCCIONES EN ESPAÑOL.
Other
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
Made for:
inov
FARMACEUTIQUE
Package Label.Principal Display Panel
NDC 69729-795-80
DOLONEURO-TROPAS
NUEVAFORMULA
NEW FORMULA
Treat Pain or Inframation caused by conditions such as:
Alivio temporal de dolores leves y malestares debidos a:
- Reumatismo
- Artritis
- Inflamacion
- Dolor
- Rheumatism
- Arthritis
- Inflamation
- Pain
20 Sachets of 4 Caplets
Analgesico/Pain Reliever
* Please review the disclaimer below.
