Ibuprofen and Pseudoephedrine HCl Tablets USP Technical Specification:
| Product Name: | Ibuprofen and Pseudoephedrine HCl Tablets USP 200mg /5mg |
| Brand Name: | Generic |
| Strength: | 200mg+5mg, 200mg+30mg |
| Dosage Form: | Caplet (Film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 40s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, FSC, COPP and CTD Dossier |
| Therapeutic use: | Anti-inflammatory drug (NSAID) /Analgesic/ Nasal Decongestant |
| Indication: | Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain. Ibuprofen and pseudoephedrine combination is used to relieve symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose. |
| Storage: | Store between 20℃ to 25℃ (68 °F to 77°F). Avoid excessive heat above 40℃ (104 °F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ibuprofen and Pseudoephedrine HCl Tablets USP 200mg /5mg
Ibuprofen and Pseudoephedrine HCl Tablets USP 200mg /30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Ibuprofen USP………………200mg
Pseudoephedrine HCl USP…………….5mg
Excipients……………Q.S.
Colour: Approved colored used.
THERAPEUTIC INDICATIONS:
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain. Ibuprofen and pseudoephedrine combination is used to relieve symptoms of cold or flu, including body aches and pains, fever, headache, or stuffy nose.
CAUTION &WARNING:
Read all warning and direction. Keep carton
WARNING: Allergy alert: Ibuprofen may cause a severe allergic reaction especially in people allergic to aspirin. Symptoms may include:
Hives
Facial swelling
Asthma (wheezing)
Shock
Skin reddening
Rash
Blisters
If an allergic reaction occurs, stop use and seek medical help right away. May cause severe stomach bleeding, the chance is higher if you:
Are age 60 or older
Have had stomach ulcer or bleeding problems
Take a blood thinning (anticoagulant) or steroids drug
Take other drugs containing prescription or nonprescription NSAIDs aspirin, ibuprofen, naproxen, or others
Take more or for a longer time than directed
HEART ATTACK AND STROCK WARNING: heart failure, and stock. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use in children under 12 years of age
If you have ever had an allergic reaction to other pain reliever/fever reducer
Right before or after heart surgery
if you are how taking prescription monoamine oxidase inhibitor(MOA) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). or 2 weeks after stopping MOA drug. if you do not know if your prescription drug contains an MOA, ask a doctor or pharmacist before taking this product.
ASK A DOCTOR BEFORE USE: if stomach bleeding warning applies to you
You have problems or serious side effects from taking pain relievers of fever reducer
You have a history of stomach problems, such as heartbum
You have high blood pressure, heart disease, liver cirrhosis, kidney disease, heart disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
You are taking diuretic
ASK DOCTORE AND PHARMACIST IF YOU ARE:
Under a doctor’s care for serious condition
Taking any other product that contains pseudoephedrine or any other nasal decongestant
IF PREGNANT OR BREAST FEEDING:
ask a health professional before use is especially important not to use ibuprofen during the last 3unonths of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help of contact a Poison Control Centre right away
DIRECTION
do not take more than directed
the smallest effective dose should be used
adults and children 12 years of age and over:
take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets maybe use.
do not use more than 6 caplets in any 24-hour period unless directed by doctor
Children under 12 years of age: not use
STORAGE:
Storage: Store between 20℃ to 25℃ (68 °F to 77°F). Avoid excessive heat above 40℃ (104 °F).