Label: PHENAGIL- phenylephrine hcl and chlorpheniramine maleate tablet
- NDC Code(s): 58552-322-01, 58552-322-02
- Packager: Gil Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 24, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
Do not use
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.
Ask a doctor before use if you have
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
When using this product
• do not exceed recommended dose
• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
- Directions
- Other Informaton
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PHENAGIL
phenylephrine hcl and chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 3.5 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code 322;GIL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-322-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2012 2 NDC:58552-322-02 12 in 1 BOX 12/14/2012 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 12/14/2012 Labeler - Gil Pharmaceutical Corp (176826592) Establishment Name Address ID/FEI Business Operations Syntho Pharmaceuticals Inc 088797407 manufacture(58552-322)