TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin liquid

TexaClear Kids Daytime Cough and Chest Congestion by

Drug Labeling and Warnings

TexaClear Kids Daytime Cough and Chest Congestion 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 and Chest Congestion

(dextromethorphan HBr, guaifenesin), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 15 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

Cough suppressant
Expectorant

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
  • 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

in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• persistent or chronic cough such as occurs with asthma
• a cough that occurs with too much phlegm (mucus)
• a sodium-restricted diet

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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.
• measure only with the dosing cup provided.
• mL= milliliter

Age	Dose
children 6 years to under 12 years	30 mL (2 dose cups) every 4 hours
children 4 years to under 6 years	15 mL (1 dose cup) every 4 hours
children under 4 years	do not use.

Other information

• each 15 mL contains: Sodium 7.5 mg
• store at room temperature 20-30°C (68-86°F)

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.
Fort Worth, TX. 76118

Principal Display Panel

TexaClear Kids Daytime Cough and Chest Congestion
NDC: 58809-216-08
8 fl. oz. (237 mL)

Dextromethorphan HBR – Cough Suppressant
Guaifenesin – Expectorant

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

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

Ages 4+

Relieves:

• Chest Congestion
• Thins & Loosens Mucus
• Cough

Distributed by:
GM Pharmaceuticals, Inc. Fort Worth, TX 76118

INGREDIENTS AND APPEARANCE

TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-216
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 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: 58809-216-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/25/2023

Labeler - GM Pharmaceuticals, INC (793000860)