ALA-HIST PE- phenylephrine hydrochloride, dexbrompheniramine maleate tablet

ALA-HIST PE by

Drug Labeling and Warnings

ALA-HIST PE by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  

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
  

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

INGREDIENTS AND APPEARANCE

ALA-HIST PE 
phenylephrine hydrochloride, dexbrompheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-782
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	purple (dark purple)	Score	2 pieces
Shape	OVAL (caplet-shaped)	Size	11mm
Flavor		Imprint Code	Poly;782
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-782-02	12 in 1 CARTON	09/15/2011
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50991-782-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2011

Labeler - Poly Pharmaceuticals, Inc. (198449894)