ALDEX D- phenylephrine hydrochloride and pyrilamine maleate suspension
Pernix Therapeutics, LLC
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.
----------
Active ingredients (in each 5mL) | Purpose |
Pyrilamine Maleate 16 mg | Antihistamine |
Phenylephrine HCl 5 mg | Nasal Decongestant |
Uses
temporarily relieves
relieves
- sneezing
- 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
Warnings
- may cause excitability, especially in children
- 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
- diabetes
- thyroid disease
- high blood pressure
- glaucoma
- a breathing problem such as emphysema, chronic bronchitis, or asthma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use
- If you or your child are taking sedatives or tranquilizers
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.
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222
Directions
- 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.
Questions?
Call 1-800-793-2145
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 65224-550-16
PERNIX
THERAPEUTICS
ALDEX® D
Antihistamine/Decongestant
(Pyrilamine/Phenylephrine)
Grape flavored suspension
Shake well
16 fl. oz. (473 mL)