TEXACLEAR SEVERE COUGH, COLD AND FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin liquid

TexaClear Severe Cough, Cold and Flu by

Drug Labeling and Warnings

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

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Choline Salicylate (NSAID)* ... 870 mg

Dextromethorphan HBr ... 20 mg

Guaifenesin ... 200 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

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

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

• 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

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

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 (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.

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

• 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 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)

INGREDIENTS AND APPEARANCE

TEXACLEAR SEVERE COUGH, COLD AND FLU 
choline salicylate, dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-217
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-217-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/25/2023

Labeler - GM Pharmaceuticals, INC (793000860)