TexaClear Kids Night Time Cold Relief

TexaClear Kids Cold Relief by

Drug Labeling and Warnings

TexaClear Kids Cold Relief by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEXACLEAR KIDS COLD RELIEF- diphenhydramine hcl phenylephrine hcl liquid 
GM Pharmaceuticals, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TexaClear Kids Night Time Cold Relief

TexaClear® Kids Night Time Cold Relief

(phenylephrine hcl, thonzylamine hcl) solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Diphenhydramine HCI 25 mg

Phenylephrine HCl 5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves symptoms occurring with a cold, hay fever, or other upper respiratory allergies:

▪ nasal congestion

▪ runny nose 

▪ sneezing

▪ itchy, watery eyes 

▪ itching of the nose or throat

Warnings

Do not use this product

▪ to sedate a child or to make a child sleepy

▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 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.

▪ with any other product containing diphenhydramine, even one used on the skin

▪ in children under 6 years of age

Ask a doctor before use if you have

▪ heart disease, high blood pressure, thyroid disease, or diabetes

▪ trouble urinating due to enlargement of the prostate gland

▪ glaucoma

▪ a cough with excessive phlegm (mucus)

▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

▪ a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

▪ taking any other oral nasal decongestant or stimulant

▪ taking sedatives or tranquilizers

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

▪ nervousness, dizziness, or sleeplessness occurs

▪ symptoms do not get better within 7 days or are accompanied by fever

▪ cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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 6 doses per 24 hrs

▪ use enclosed dose cup and keep with product

▪ mL= milliliter

• adults & children 12 yrs & over: 60 mL every 4 hrs
• children 6 to under 12 yrs: 30 mL every 4 hrs
• children under 6 yrs: do not use.

Other information

▪ each 30 mL contains: Sodium 16 mg

▪ tamper evident: Do not use if foil seal under cap is broken or missing.

▪ read all product information before using

▪ store at room temperature 68-86°F (20-30°C)

▪ avoid excessive heat and humidity

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.

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

KEEP LEAFLET AFTER OPENING

R041417

Principal Display Panel

TexaClear® Kids Nighttime Cold Relief

NDC: 58809-955-08

8 fl. oz. (237 mL)

Diphenhydramine HCl - Antihistamine

Phenylephrine HCl – Nasal Decongestant

Tamper evident: do not use if foil seal under cap is broken on missing

• Gluten Free
  
• Dye Free
  
• Sugar Free
  
• Alcohol Free
  
• Acetaminophen Free

Ages 6+

Relieves:

• Runny Nose
  
• Sneezing
  
• Watery Eyes
  
• Nasal Congestion
  

Distributed by:

GM Pharmaceuticals, Inc. Arlington, TX 76015

TEXACLEAR KIDS COLD RELIEF 
diphenhydramine hcl phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-955
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
PROPYL GALLATE (UNII: 8D4SNN7V92)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-955-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2015	04/30/2019

Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2019

Document Id: becd68db-2889-4e98-893b-0519d565a272

34390-5

Set id: 3bde7a0e-22c4-5fcb-e054-00144ff88e88

Version: 3

Effective Time: 20191118