Ala-hist Ir 2 Mg Tablets

Ala-hist Ir 2 Mg Tablets
SPL v11
SPL
SPL Set ID 0d203b5c-8b10-428b-8703-17be6b4ce6eb
Route
ORAL
Published
Effective Date 2013-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexbrompheniramine (2 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Silicon Dioxide Cellulose, Microcrystalline Croscarmellose Sodium Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: Poly;783 Shape: oval Color: green Size: 11 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-08-22

Description

Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg

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
Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
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. 


Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Questions?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS  39355

Rev. 02/12

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.

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

Rev. 02/12

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.

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
Keep Out of Reach of Children.

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


Structured Label Content

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
Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

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
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. 


Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Questions?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS  39355

Rev. 02/12

Other Information (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.

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

Rev. 02/12

Inactive Ingredients (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.

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
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.


Advanced Ingredient Data


Raw Label Data

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