TEXACLEAR KIDS COUGH AND COLD- dextromethorphan hbr guaifenesin phenyephrine hcl liquid

TexaClear Kids Cough and Cold by

Drug Labeling and Warnings

TexaClear Kids Cough and Cold 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® Kids Daytime Cough & Cold

(dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  
• temporarily relieves:   
  
• the intensity of coughing
  
• nasal congestion due to a cold  
  
• stuffy nose
  
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings 

Do not exceed recommended dosage.

Do not use

• 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.
  
• in children under 6 years of age
  

Ask a doctor before use if you have

• heart disease, thyroid disease, diabetes, or high blood pressure
  
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  
• a cough that occurs with too much phlegm (mucus)
  
• trouble urinating due to an enlarged prostate gland
  
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant

When using this product

do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
  
• symptoms do not improve within 7 days, or are 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-hour period

■ use enclosed (30 mL) dose cup  ■ mL = milliliter

■ dose every 4 hours

■ adults and children 12 years and over:60 mL (2 dose cups)

■ children 6 to under 12 years: 30 mL (1 dose cup)

■ children under 6 years: do not use

Other information

• each 30 mL contains: Sodium 15 mg
  
• read all product information before using
  
• store at room temperature 68-86°F (20-30°C)

Inactive ingredients

citric acid, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucralose

Questions or comments?

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX. 76015

Principal Display Panel

TexaClear® Kids Daytime Cough & Cold
NDC: 58809-950-08
8 fl. oz. (237 mL)

 

Dextromethorphan HBR – Cough Suppressant
Guaifenesin – Expectorant
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:

• Nasal & Chest Congestion
  
• Thins & Loosens Mucus
  
• Cough
  

Distributed by:
GM Pharmaceuticals, Inc. Arlington, TX 76015

INGREDIENTS AND APPEARANCE

TEXACLEAR KIDS COUGH AND COLD 
dextromethorphan hbr guaifenesin phenyephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-950
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-950-08	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

Labeler - GM Pharmaceuticals, INC (793000860)