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

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

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 warnings

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

■ 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

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

■ 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)

PDP-10 PDP-2PDP-3

TEXACLEAR NIGHT TIME COUGH COLD/FLU 
choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-372
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 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:58809-372-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/201410/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/23/201410/31/2024
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
Document Id: 0b27af73-e2af-0312-e063-6294a90a693e
Set id: 17a39de8-1702-0711-e054-00144ff8d46c
Version: 6
Effective Time: 20231127
 
GM Pharmaceuticals, INC