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FDA LABEL GENERIC: Choline MFR: GM Pharmaceuticals, INC

Choline Salicylate 29 Mg/ml / Dextromethorphan Hydrobromide 0.667 Mg/ml / Guaifenesin 6.67 Mg/ml Oral Solution

TexaClear Severe Cough Cold & Flu Relief - choline salicylate, dextromethorphan hydrobromide, guaifenesin, liquid

GM Pharmaceuticals, Inc.

Drug Facts

Choline Salicylate (NSAID)* ... 870 mg

Dextromethorphan HBr ... 20 mg

Guaifenesin ... 200 mg

*nonsteroidal anti-inflammatory drug

Pain reliever / fever reducer

Cough suppressant

Expectorant

INDICATIONS AND USAGE

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

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.

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
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
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
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

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.

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

DOSAGE AND ADMINISTRATION

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
each 30mL contains: Sodium 15 mg read all product information before using store at 20° to 30°C (68° to 86°F)

citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Call 1-888-535-0305 9 a.m. – 5p.m. CST

ASK A DOCTOR

NDC 58809-217-08

TEXACLEAR SEVERE COUGH COLD & FLU

8 fl oz (237 mL)