DOSAGE & ADMINISTRATION SECTION.

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

INACTIVE INGREDIENT SECTION.

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

INDICATIONS & USAGE SECTION.

Uses. Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:runny nosesneezingitching of the nose or throatitchy, watery eyes. runny nose. sneezing. itching of the nose or throat. itchy, watery eyes.

OTC - ACTIVE INGREDIENT SECTION.

Drug Facts. Active ingredients(in each tablet)Dexbrompheniramine Maleate mg. Purpose. Antihistamine.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product. excitability may occur, especially in childrenmay cause drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase the drowsiness effectuse caution when driving motor vehicle or operating machinery. 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 motor vehicle or operating machinery. If pregnant or breast-feeding, ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - WHEN USING SECTION.

When using this product. excitability may occur, especially in childrenmay cause drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase the drowsiness effectuse caution when driving motor vehicle or operating machinery. 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 motor vehicle or operating machinery. If pregnant or breast-feeding, ask health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

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 mg Tablets AntihistamineEach tablet contains: Dexbrompheniramine Maleate.........2 mg 60 TabletsUsual Dosage: See product foldout for full prescribing information Tamper evident by foil seal under cap. Do notuse if foil seal is broken or missing.KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15-30C (59-86F). Manufactured for: Poly Pharmaceuticals Rev. 02/12. label. label2.

STORAGE AND HANDLING SECTION.

Other information. Store at 15 30C (59 86F).Supplied in tight, light-resistant container with child-resistant cap.Contains color additives including FD&C Yellow No. (tartrazine).Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed Poly bisect 783 on one side and plain on the other.

WARNINGS SECTION.

Warnings. Ask doctor before use if you havea breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to enlargement of the prostate gland. breathing problem such as emphysema or chronic bronchitis. glaucoma. trouble urinating due to enlargement of the prostate gland. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product. excitability may occur, especially in childrenmay cause drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase the drowsiness effectuse caution when driving motor vehicle or operating machinery. 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 motor vehicle or operating machinery. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.