TEXACLEAR NIGHT TIME COUGH COLD/FLU- choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

TEXACLEAR NIGHT TIME COUGH COLD/FLU by

Drug Labeling and Warnings

TEXACLEAR NIGHT TIME 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 NIGHT TIME COUGH COLD/FLU- (choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride) liquid

GM Pharmaceuticals, Inc.

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TEXACLEAR NIGHT TIME COUGH COLD/FLU

Drug Facts

Active ingredients (in each 30 mL)

Choline Salicylate (NSAID)* 870 mg

Diphenhydramine HCl 50 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Antihistamine  

Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  
• nasal congestion
  
• minor aches and pains
  
• runny nose
  
• sneezing
  
• watery eyes
  
• sore throat
  
• headache
  
• temporarily reduces fever

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

■ with any other drug containing diphenhydramine, even one used on the skin

■ 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, thyroid disease, or glaucoma

■ you have difficulty in urination due to enlargement of the prostate gland

■ you have a breathing problem such as emphysema or chronic bronchitis            

■ 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 sedatives or tranquilizers   

■ taking a diuretic

When using this product

■ do not use more than directed

■ marked drowsiness may occur  

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

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
  
• keep dosage cup with product
  
• mL=milliliter

• adults and children12 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

■ store at 20° to 30°C (68° to 86°F)   

■ this package is child-resistant

■ read all product information before using

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. - 5 p.m. CST

PRINCIPAL DISPLAY PANEL

NDC: 58809-372-08
TEXACLEAR
NIGHTTIME
COLD & FLU
RELIEF
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

TEXACLEAR NIGHT TIME COUGH COLD/FLU 
choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-372
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 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: 58809-372-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/23/2014

Labeler - GM Pharmaceuticals, INC (793000860)