TEXACLEAR PAIN AND CHEST CONGESTION RELIEF- choline salicylate,guaifenesin liquid 
GM Pharmaceuticals, INC

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TexaClear Pain & Chest Congestion Relief

TexaClear Pain & Chest Congestion Relief

(Choline Salicylate, Guaifenesin)

NDC: 58809-218-08

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Choline Salicylate (NSAID)* 870 mg

Guaifenesin 200 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

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

  • if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer.
  • 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 a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • you are taking a diuretic
  • have asthma

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

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.
  • 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

AgeDose
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 anhydrous, 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

PRINCIPAL DISPLAY PANEL

NDC 58809-218-08
TexaClear Pain & Chest Congestion Relief
8 fl oz(237 mL)

PDP

Drug Facts

TEXACLEAR PAIN AND CHEST CONGESTION RELIEF 
choline salicylate,guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-218
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
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:58809-218-08237 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: 0b619327-ee50-6c40-e063-6394a90adff0
Set id: 672bc78a-2c71-4135-b64a-2b8c40ac688c
Version: 1
Effective Time: 20231130
 
GM Pharmaceuticals, INC