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

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF by

Drug Labeling and Warnings

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 16 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 & Sinus Pain Relief
8 fl oz(237 mL)

INGREDIENTS AND APPEARANCE

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF 
choline salicylate,guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-346
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 30 mL
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-346-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/21/2014

Labeler - GM Pharmaceuticals, INC (793000860)