FDA Label for Texaclear Congestion And Pain Sinus Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Texaclear Congestion And Pain Sinus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 30 Ml)
Choline Salicylate (NSAID)* 870 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever / fever reducer
Expectorant
Nasal decongestant
Uses
temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies
- nasal congestion
- minor aches and pains
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive
Warnings
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:
- hives
- rash
- shock
- skin reddening
- facial swelling
- asthma (wheezing)
- 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
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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 a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- you have asthma
- you have a sodium restricted diet.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking a prescription drug for anticoagulation (thinning the blood) diabetes, gout, or arthritis.
- under a doctor’s care for any serious condition
- taking a diuretic.
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 occur
- 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 sleeplessness occurs
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use salicylates (NSAID) during the last 3 months 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 or contact a Poison Control Center right away.
Directions
- do not exceed recommended dosage.
- do not take more than 6 doses in any 24-hour period.
- use enclosed dose cup
- keep dosage cup with product
- mL= milliliter
adults and children 12 years of age and over: | 30 mL every 4 hours |
children under 12 years of age: | do not use. |
Other Information
- each 30mL contains: Sodium 17 mg
- tamper evident: Do not use if foil seal under cap is broken or missing.
- read all product information before using
- store at 68° to 86°F (20° to 30°C)
- avoid excessive heat and humidity
Inactive Ingredients
anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions Or Comments?
Call 1-888-535-0305 9 a.m. - 5 p.m. CST
Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX. 76015
KEEP LEAFLET AFTER OPENING
M-R080917
Principal Display Panel
NDC 58809-346-08
TexaClear
Congestion & Pain
SINUS
RELIEF
8 fl oz(237 mL)
* Please review the disclaimer below.