Label: ALDEX D- phenylephrine hydrochloride and pyrilamine maleate suspension
- NDC Code(s): 65224-550-16
- Packager: Pernix Therapeutics, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each 5mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant
- runny nose
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- nasal congestion due to the common cold
- 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
- thyroid disease
- high blood pressure
- a breathing problem such as emphysema, chronic bronchitis, or asthma
- trouble urinating due to an enlarged prostate gland
When using this product
- Do not exceed recommended dosage.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- if symptoms do not improve within 7 days or are accompanied by fever.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222
- take every 6 hours
- do not take more than 4 doses in 24 hours or as directed by a doctor
Adults and children 12 years of age and older 1 to 2 teaspoonsful Children 6 to under 12 years of age 1 teaspoonful Children under 6 years of age Ask a doctor
- Other Information
store at controlled room temperature 20°-25°C (68°-77°F)
- Tamper Evident: Do not use if seal is broken or missing.
- Inactive ingredients
Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.Close
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Grape flavored suspension
16 fl. oz. (473 mL)
- INGREDIENTS AND APPEARANCE
phenylephrine hydrochloride and pyrilamine maleate suspension
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65224-550 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 16 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN GRAPE MAGNESIUM ALUMINUM SILICATE METHYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE XANTHAN GUM TANNIC ACID Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65224-550-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/01/2010 Labeler - Pernix Therapeutics, LLC (004672296)