Label: TEXACLEAR- allergy relief tablet
- NDC Code(s): 58809-186-30
- 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.
Drug Label Information
Updated August 3, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (per tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- a cough that occurs with too much phlegm (mucus)
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TEXACLEAR
allergy relief tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-186 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 25 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code AC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-186-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2015 Labeler - GM Pharmaceuticals, INC (793000860)