Texaclear Severe Cough, Cold & Flu Relief

Texaclear Severe Cough, Cold & Flu Relief
SPL v3
SPL
SPL Set ID cb99e5b3-1908-43c9-b31f-d35e7ce58b44
Route
ORAL
Published
Effective Date 2023-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (870 mg) Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

TexaClear Severe Cough Cold & Flu Relief - choline salicylate, dextromethorphan hydrobromide, guaifenesin, liquid GM Pharmaceuticals, Inc. Drug Facts

Purpose

Pain reliever / fever reducer Cough suppressant Expectorant


Medication Information

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

Description

TexaClear Severe Cough Cold & Flu Relief - choline salicylate, dextromethorphan hydrobromide, guaifenesin, liquid GM Pharmaceuticals, Inc. Drug Facts

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
Section 42229-5

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

GM Pharmaceuticals, Inc.

Drug Facts

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.

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

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

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. – 5p.m. CST

Principal Display Panel

NDC 58809-217-08

TEXACLEAR SEVERE COUGH COLD & FLU

8 fl oz (237 mL)

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
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.

Active Ingredients (in Each 30 Ml)

Choline Salicylate (NSAID)* ... 870 mg

Dextromethorphan HBr ... 20 mg

Guaifenesin ... 200 mg

*nonsteroidal anti-inflammatory drug

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

Structured Label Content

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
Section 42229-5 (42229-5)

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

GM Pharmaceuticals, Inc.

Drug Facts

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

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.

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

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

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-217-08

TEXACLEAR SEVERE COUGH COLD & FLU

8 fl oz (237 mL)

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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, (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. (Keep out of reach of children.)

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

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Choline Salicylate (NSAID)* ... 870 mg

Dextromethorphan HBr ... 20 mg

Guaifenesin ... 200 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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