Texaclear Night Time Cough Cold/flu Recall
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Questions & Answers
Side Effects & Adverse Reactions
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
- skin reddening
- facial swelling
- asthma (wheezing)
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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
- if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer.
- with any other drug containing diphenhydramine, even one used on the skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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.
- in children under 12 years of age
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, or thyroid disease
- you have a cough with excessive phlegm (mucus)
- you have difficulty in urination due to enlargement of the prostate gland
- you have glaucoma
- you have breathing problems such as emphysema or chronic bronchitis
- you have persistent or chronic cough such as occus with smoking, asthma, chronic bronchitis, or emphysema
- you have a sodium restricted diet.
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for anti-coagulation (thinning the blood), diabetes, gout, arthritis.
- under a doctor's care for any serious condition
- taking a diuretic
- taking sedatives or tranquilizers
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- pain, cough, 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 ocur
- ringing in the ears or a loss of hearing occurs
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- nervousness, dizziness, or sleelessness occurs
- you experiens any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have a stomach pain that does not get better
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Temporarily relieves these common cold and flu symptoms:
- nasal congestion
- minor aches and pains
- sore throat
- runny nose
- watery eyes
- temporarily reduces fever
- controls cough to help you get to sleep
There is currently no drug history available for this drug.
There are no additional details available for this product.
Texaclear Night Time Cough Cold/flu Manufacturers
Gm Pharmaceuticals, Inc.
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