Alahist Pe

Alahist Pe
SPL v7
SPL
SPL Set ID ada2d582-5813-2029-e053-2a95a90ae567
Route
ORAL
Published
Effective Date 2020-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexbrompheniramine (2 mg) Phenylephrine (7.5 mg)
Inactive Ingredients
Magnesium Stearate Fd&c Blue No. 1 Silicon Dioxide Croscarmellose Sodium Starch, Corn D&c Red No. 27 Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: Poly;782 Shape: capsule Color: purple Size: 11 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-24

Description

(in each tablet) Dexbrompheniramine Maleate 2 mg Phenylephrine Hydrochloride 7.5 mg

Purpose

Dexbrompheniramine Maleate- -Antihistamine Phenylephrine Hydrochloride-- Nasal Decongestant


Medication Information

Purpose



Dexbrompheniramine Maleate- -Antihistamine

Phenylephrine Hydrochloride-- Nasal Decongestant

Description

(in each tablet) Dexbrompheniramine Maleate 2 mg Phenylephrine Hydrochloride 7.5 mg

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, water eyes
  • nasal congestion
  • reduces swelling of nasal passages
Directions
Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.

Alahist Pe Label

Manufactured for

Poly Pharmaceuticals

Huntsville, AL 35763

Other Information

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

Active Ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Phenylephrine Hydrochloride 7.5 mg

Inactive Ingredients

Croscarmellose sodium, D&C Red # 27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions? Comments?

Call 1-800-882-1041

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.

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 Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breastfeeding

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.

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



Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers.


Structured Label Content

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, water eyes
  • nasal congestion
  • reduces swelling of nasal passages
Purpose



Dexbrompheniramine Maleate- -Antihistamine

Phenylephrine Hydrochloride-- Nasal Decongestant

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

Alahist Pe Label (Alahist PE Label)

Manufactured for

Poly Pharmaceuticals

Huntsville, AL 35763

Other Information

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

Active Ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Phenylephrine Hydrochloride 7.5 mg

Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, D&C Red # 27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions? Comments?

Call 1-800-882-1041

Do Not Use This Product (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.

When Using This Product (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 Doctor If (Stop use and Ask Doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breastfeeding (If Pregnant or Breastfeeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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



Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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