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ALA-HIST PE (phenylephrine hydrochloride 10 mg dexbrompheniramine maleate 2 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Poly Pharmaceuticals, Inc.

Generic: phenylephrine hydrochloride, dexbrompheniramine maleate

ALA-HIST PE tablet - (phenylephrine hydrochloride 10 mg dexbrompheniramine maleate 2 mg) image

IMPRINT: POLY 782     SHAPE: oval
    COLOR: purple    SCORE: 2

  1. FDA Adverse Reactions

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Drug Facts


Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg Phenylephrine Hydrochloride 10 mg

Purpose


Antihistamine Nasal Decongestant

Uses


Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings


Do not exceed recommended dosage.

Do not use this product

  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlargement of the prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever

OTC - PREGNANCY OR BREAST FEEDING SECTION


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.

Directions

Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours
Children under 6 years of age: Consult a doctor

Other Information


Store at 15° - 30°C (59° - 86°F).  Supplied in a tight, light-resistant container with a child-resistant cap.  Ala-Hist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?


Call1-800-882-1041

Manufactured for: Poly Pharmaceuticals

Huntsville, AL

Product Packaging


The packaging below represents the labeling currently used.

Principal display panel and side panel for 90 tablets label:

NDC 50991-782-90

ALA-HIST PE Tablets

Antihistamine • Nasal Decongestant

Each tablet contains: Dexbrompheniramine Maleate......................2 mg Phenylephrine Hydrochloride......................10 mg

90 Tablets

Usual Dosage: See product foldout for full prescribing information.

Tamper evident by foil seal under cap. Do not use if foil seal isbroken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at controlled room temperature between 15°-30°C (59°-86°F).

Manufactured for: Poly Pharmaceuticals

Rev. 06/19





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