ALA-HIST PE - phenylephrine hydrochloride and dexbrompheniramine maleate tablet
Poly Pharmaceuticals
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.
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Drug Facts
Active ingredientsPhenylephrine Hydrochloride................10 mg
Dexbrompheniramine Maleate................2 mg
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itching of the nose or throat
- itchy, water eyes
Warnings
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur. Do not take this product unless directed by a doctor if you have- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland.
When using this product it may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. May cause excitability especially in children. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not take this product if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask a doctor or pharmacist before 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. Do not take this product if you are taking sedatives or tranquilizes, without first consulting your doctor.
Directions
Adults and children 12 years of age and older: 1 tablet every 4-6 hours, not to exceed 6 tablets in a 24 hour period. Children 6 to 12 years of age: half tablet every 4-6 hours, not to exceed 3 tablets in a 24 hour period. Children 6 years of age and younger: Consult a physician.Other information
Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30° C (59°-86° F).Ala-Hist PE Tablets are purple, caplet-shaped, scored tablets, debossed Poly 782.
Inactive ingredients
dicalcium phosphate dihydrate, silicon dioxide, microcrystalline cellulose, croscarmellose, purple dye, and magnesium stearate.Product Packaging
The packaging below represents the labeling currently used.Principal display panel and side panel for 60 tablets label:
NDC 50991-782-60
ALA-HIST PE
Tablets
Nasal Decongestant • Antihistamine
Each tablet contains:
Phenylephrine Hydrochloride...............10 mg
Dexbrompheniramine Maleate...............2 mg
Usual Dosage: See product foldout for full prescribing information.
KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355
Rev. 06/11
| ALA-HIST PE
phenylephrine hydrochloride, dexbrompheniramine maleate tablet |
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| Labeler - Poly Pharmaceuticals (198449894) |
Revised: 09/2011
Document Id: b55c982e-96b0-4576-bb6b-3c3599c005c3
Set id: 3a98ffbd-f864-4550-a2ba-568feb8bd272
Version: 2
Effective Time: 20110915
Poly Pharmaceuticals