TEXACLEAR CONGESTION AND PAIN SINUS RELIEF

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF

Drug Labeling and Warnings

Drug Details

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TEXACLEAR CONGESTION AND PAIN SINUS RELIEF- choline salicylate,guaifenesin, phenylephrine hydrochloride liquid 
GM Pharmaceuticals, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TEXACLEAR CONGESTION AND PAIN SINUS RELIEF

TexaClear Congestion and Pain Sinus Relief

(Choline Salicylate, Guaifenesin, Phenylephrine HCl)

NDC: 58809-346-08

GM Pharmaceuticals, Inc.

Drug Facts

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)

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.
  • 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.

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 (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)

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-346-08 TexaClear Congestion & Pain SINUS RELIEF 8 fl oz(237 mL) " src="https://fda.report/DailyMed/178f648e-9539-71b9-e054-00144ff8d46c/texaclear-congestion-and-pain-sinus-relief-01.jpg&archiveid=298270"/>

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-346-08 TexaClear Congestion & Pain SINUS RELIEF 8 fl oz(237 mL) " src="https://fda.report/DailyMed/178f648e-9539-71b9-e054-00144ff8d46c/texaclear-congestion-and-pain-sinus-relief-02.jpg&archiveid=298270"/>

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-346-08 TexaClear Congestion & Pain SINUS RELIEF 8 fl oz(237 mL) " src="https://fda.report/DailyMed/178f648e-9539-71b9-e054-00144ff8d46c/texaclear-congestion-and-pain-sinus-relief-03.jpg&archiveid=298270"/>

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF 
choline salicylate,guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58809-346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58809-346-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/21/2014
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 8/2017
 
GM Pharmaceuticals, INC


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