ALA-HIST IR description, usages, side effects, indications, overdosage, supplying and lots more!

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ALA-HIST IR

Poly Pharmaceuticals, Inc.

ALA-HIST IR 2 mg Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Purpose

Antihistamine

ALA-HIST IR Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

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

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

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. 

 

ALA-HIST IR Other information

Store at 15° - 30°C (59° - 86°F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions?

Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355

Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-783-60 

               
ALA-HIST IR
2 mg Tablets


Antihistamine

Each tablet contains:
Dexbrompheniramine Maleate.........2 mg

60 Tablets

Usual Dosage:  See product foldout for full
prescribing information

Tamper evident by foil seal under cap.  Do not

use if foil seal is broken or missing.


KEEP THIS AND ALL DRUGS OUT OF
REACH OF CHILDREN.

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

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355

Rev. 02/12

ALA-HIST IR

ALA-HIST IR

ALA-HIST IR

Dexbrompheniramine Maleate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50991-783
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dexbrompheniramine Maleate DEXBROMPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SILICON DIOXIDE
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
green (dark green) 11 mm Poly;783 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50991-783-60 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-08-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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