Label: TEXACLEAR KIDS ALLERGY- chlophedianol hcl pyrilamine maleate liquid
- NDC Code(s): 58809-925-08
- Packager: GM Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 13, 2022
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- Active Ingredients
Do not exceed recommended dosage.
Ask doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to the enlargment of the prostate gland
- cough that occurs with too much phlegm(mucus)
- a breathing problem such as emphysema or chronic bronchitis
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Other Information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL
TexaClear® Kids Allergy + Cough
8 fl. oz. (237 mL)
Chlophedianol HCl – Cough Suppressant
Pyrilamine Maleate – Antihistamine
Tamper evident: do not use if foil seal under cap is broken on missing
- Gluten Free
- Dye Free
- Sugar Free
- Alcohol Free
- Acetaminophen Free
Dose every 6 to 8 hours
- Runny Nose
- Watery Eyes
- Itchy Nose & Throat
GM Pharmaceuticals, Inc. Arlington, TX 76015
INGREDIENTS AND APPEARANCE
TEXACLEAR KIDS ALLERGY
chlophedianol hcl pyrilamine maleate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-925 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg in 30 mL PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 25 mg in 30 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-925-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/15/2016 Labeler - GM Pharmaceuticals, Inc. (793000860)