Label: DAYCLEAR ALLERGY RELIEF CHEWABLES- chlophedianol hydrochloride, pyrilamine maleate tablet, chewable
- NDC Code(s): 58809-222-24
- 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 January 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ cough that occurs with too much phlegm (mucus)
■ a breathing problem such as emphysema or chronic bronchitis
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAYCLEAR ALLERGY RELIEF CHEWABLES
chlophedianol hydrochloride, pyrilamine maleate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-222 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 25 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) LEVOMENTHOL (UNII: BZ1R15MTK7) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor MINT Imprint Code DC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-222-24 1 in 1 CARTON 01/02/2020 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/02/2020 Labeler - GM Pharmaceuticals, INC (793000860)