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

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

PDP

Drug Facts

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58809-216-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2023

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

Labeler - GM Pharmaceuticals, INC (793000860)