Texaclear Kids Daytime Cough And Chest Congestion

Texaclear Kids Daytime Cough And Chest Congestion
SPL v2
SPL
SPL Set ID f9cdc7a2-1972-4cb8-9234-6220f40c2b8c
Route
ORAL
Published
Effective Date 2023-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Maltitol Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

TexaClear Kids Daytime Cough and Chest Congestion (dextromethorphan HBr, guaifenesin), solution GM Pharmaceuticals, Inc. Drug Facts

Purpose

Cough suppressant Expectorant


Medication Information

Warnings and Precautions

Do not exceed recommended dosage.

Purpose

Cough suppressant

Expectorant

Description

TexaClear Kids Daytime Cough and Chest Congestion (dextromethorphan HBr, guaifenesin), solution GM Pharmaceuticals, Inc. Drug Facts

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
Section 42229-5

TexaClear Kids Daytime Cough and Chest Congestion

(dextromethorphan HBr, guaifenesin), solution

GM Pharmaceuticals, Inc.

Drug Facts

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.
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.

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

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

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

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.

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

Structured Label Content

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 and Precautions (34071-1)

Do not exceed recommended dosage.

Section 42229-5 (42229-5)

TexaClear Kids Daytime Cough and Chest Congestion

(dextromethorphan HBr, guaifenesin), solution

GM Pharmaceuticals, Inc.

Drug Facts

Purpose

Cough suppressant

Expectorant

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.
Do Not Use (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.

Other Information (Other information)
  • each 15 mL contains: Sodium 7.5 mg
  • store at room temperature 20-30°C (68-86°F)
Active Ingredients  (Active ingredients )

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If the Child Has (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

Advanced Ingredient Data


Raw Label Data

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