TEXACLEAR KIDS COUGH AND COLD- dextromethorphan hbr guaifenesin phenyephrine hcl liquid 
GM Pharmaceuticals, INC

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TexaClear Kids Daytime cough and cold

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

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

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

Ages 6+

Relieves:

Distributed by:

GM Pharmaceuticals, Inc. Arlington, TX 76015

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TEXACLEAR KIDS COUGH AND COLD 
dextromethorphan hbr guaifenesin phenyephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-950
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-950-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/201512/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/15/201512/31/2024
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
Document Id: 0b282f06-3147-8ed1-e063-6294a90a6cd5
Set id: 3bc591c6-2f94-5cbe-e054-00144ff8d46c
Version: 8
Effective Time: 20231127
 
GM Pharmaceuticals, INC