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

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