Indications and uses
temporarily relieves symptoms occurring with a cold, hay fever, or other upper respiratory allergies: ▪ nasal congestion ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat
TexaClear Kids Cold Relief
- Manufacturer
- GM Pharmaceuticals, INC
- Effective date
- 2017-04-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:05:30
Label at a glance#
ProductTexaClear Kids Cold Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
▪ do not exceed 6 doses per 24 hrs ▪ use enclosed dose cup and keep with product ▪ mL= milliliter adults & children 12 yrs & over: 60 mL every 4 hrs children 6 to under 12 yrs: 30 mL every 4 hrs children under 6 yrs: do not use.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
TexaClear® Kids Night Time Cold Relief
(phenylephrine hcl, thonzylamine hcl) solution
GM Pharmaceuticals, Inc.
Drug Facts
Active ingredients (in each 30 mL)
Diphenhydramine HCI 25 mg
Phenylephrine HCl 5 mg
Purpose
Antihistamine
Nasal decongestant
Uses
temporarily relieves symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
▪ nasal congestion
▪ runny nose
▪ sneezing
▪ itchy, watery eyes
▪ itching of the nose or throat
Warnings
Do not use this product
▪ to sedate a child or to make a child sleepy
▪ 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.
▪ with any other product containing diphenhydramine, even one used on the skin
▪ in children under 6 years of age
Ask a doctor before use if you have
▪ heart disease, high blood pressure, thyroid disease, or diabetes
▪ trouble urinating due to enlargement of the prostate gland
▪ glaucoma
▪ a cough with excessive phlegm (mucus)
▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
▪ a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
▪ taking any other oral nasal decongestant or stimulant
▪ taking sedatives or tranquilizers
When using this product
▪ do not use more than directed
▪ marked drowsiness may occur
▪ avoid alcoholic drinks
▪ alcohol, sedatives, and tranquilizers may increase drowsiness
▪ be careful when driving a motor vehicle or operating machinery
▪ excitability may occur, especially in children
Stop use and ask a doctor if
▪ nervousness, dizziness, or sleeplessness occurs
▪ symptoms do not get better within 7 days or are accompanied by fever
▪ cough lasts more than 7 days, comes back, or is 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 hrs
▪ use enclosed dose cup and keep with product
▪ mL= milliliter
| adults & children 12 yrs & over: | 60 mL every 4 hrs |
| children 6 to under 12 yrs: | 30 mL every 4 hrs |
| children under 6 yrs: | do not use. |
Other information
▪ each 30 mL contains: Sodium 16 mg
▪ tamper evident: Do not use if foil seal under cap is broken or missing.
▪ read all product information before using
▪ store at room temperature 68-86°F (20-30°C)
▪ avoid excessive heat and humidity
Inactive ingredients
citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions or comments?
Call 1-888-535-0305 9 a.m. - 5 p.m. CST.
Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015
KEEP LEAFLET AFTER OPENING
R041417
Principal Display Panel
TexaClear® Kids Nighttime Cold Relief
NDC 58809-955-08
8 fl. oz. (237 mL)
Diphenhydramine HCl - Antihistamine
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:
- Runny Nose
- Sneezing
- Watery Eyes
- Nasal Congestion
Distributed by:
GM Pharmaceuticals, Inc. Arlington, TX 76015
Products#
Every source-derived product name is available through these pages.
- TexaClear Kids Cold Relief
- Diphenhydramine HCl Phenylephrine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- PROPYLENE GLYCOL
- GLYCERIN
- SODIUM BENZOATE
- SODIUM CITRATE
- ANHYDROUS CITRIC ACID
- SORBITOL
- SUCRALOSE
- WATER
- EDETIC ACID
- PROPYL GALLATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58809-955 | 58809-955-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| EDETIC ACID | 9G34HU7RV0 | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| becd68db-2889-4e98-893b-0519d565a272 | 3bde7a0e-22c4-5fcb-e054-00144ff88e88 | 2019-11-18 | Warnings | 3bde7a0e-22c4-5fcb-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.