TEXACLEAR DAYTIME COUGH COLD/FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

TEXACLEAR DAYTIME COUGH COLD/FLU by

Drug Labeling and Warnings

TEXACLEAR DAYTIME COUGH COLD/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 DAYTIME COUGH COLD/FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

GM Pharmaceuticals, Inc.

TEXACLEAR DAYTIME COUGH COLD/FLU

Drug Facts

Active ingredients (in each 30 mL)

Choline Salicylate (NSAID)* 870 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

• Cough
  
• nasal congestion
  
• minor aches and pains
  
• sore throat
  
• headache
  
• 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 warnings:

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 difficulty in urination due to enlargement of the prostate gland
  
• 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: 58809-391-08
TEXACLEAR
DAYTIME
COUGH
COLD & FLU
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

TEXACLEAR DAYTIME COUGH COLD/FLU 
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-391
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 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: 58809-391-08	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)