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

----------

TexaClear Severe Cough, Cold & Flu Relief

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

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:

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

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

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)

PDP

Drug Facts

TEXACLEAR SEVERE COUGH, COLD AND FLU 
choline salicylate, dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-217
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-217-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/25/2023
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
Document Id: 0b616cb8-b8d8-651b-e063-6394a90a4080
Set id: cb99e5b3-1908-43c9-b31f-d35e7ce58b44
Version: 1
Effective Time: 20231130
 
GM Pharmaceuticals, INC