TexaClear Severe Cough, Cold and Flu CHOLINE SALICYLATE DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN GM PHARMACEUTICALS, INC FDA Approved Uses temporarily relieves these common cold and flu symptoms: Cough headache sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Substance Choline Salicylate
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL) Choline Salicylate (NSAID)* ... 870 mg Dextromethorphan HBr ... 20 mg Guaifenesin ... 200 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients citric acid glycerin propylene glycol purified water sodium benzoate sodium citrate sodium saccharin sorbitol
Strengths
30 ml 870 mg 20 mg 200 mg
Quantities
237 ml
Treats Conditions
Uses Temporarily Relieves These Common Cold And Flu Symptoms Cough Headache Sore Throat Minor Aches And Pains Temporarily Reduces Fever Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0358809217083
UNII
KD510K1IQW 9D2RTI9KYH 495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL NDC 58809-217-08 TEXACLEAR SEVERE COUGH COLD & FLU 8 fl oz (237 mL) PDP Drug Facts

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 58809-217-08 TEXACLEAR SEVERE COUGH COLD & FLU 8 fl oz (237 mL) PDP Drug Facts

Overview

Uses temporarily relieves these common cold and flu symptoms: Cough headache sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: Cough headache sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions do not exceed recommended dosage . do not take more than 6 doses in any 24-hour period. use enclosed dose cup and keep with product mL= milliliter Age Dose adults and children 12 years of age and over: 30 mL every 4 hours. children under 12 years of age: do not use

Warnings & Precautions
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) 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 in children under 12 years of age 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 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 chronic pulmonary disease or shortness of breath you have a cough with excessive phlegm (mucus) you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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 When using this product do not use more than directed 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 (NSAIDs) 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.
Purpose

Purpose Pain reliever / fever reducer Cough suppressant Expectorant

Do Not Use

Do not use in children under 12 years of age 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

When Using

When using this product do not use more than directed

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? Call 1-888-535-0305 9 a.m. – 5p.m. CST


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