RU-HIST D- brompheniramine maleate and phenylephrine hydrochloride tablet, coated

Ru-Hist D by

Drug Labeling and Warnings

Ru-Hist D by is a Otc medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients Each tablet contains:	Purpose
Brompheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	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
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus
• difficulty in urination due to enlargement of the prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• if symptoms do not improve within 7 days or are accompanied by fever
• new symptoms occur

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

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

• 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

Other information

Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

Call 866-633-9033

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC: 28595-900-60

Ru-Hist D
Antihistamine Nasal Decongestant

Each tablet contains:
Brompheniramine Maleate    4 mg
Phenylephrine HCl    10 mg

Tamper evident by foil seal under cap. Do not use if foil seal
is broken or missing.

New Formula

ALLEGIS PHARMACEUTICALS

Manufactured for:
Allegis Pharmaceuticals, LLC
Canton, MS 39046

60 Tablets

INGREDIENTS AND APPEARANCE

RU-HIST D 
brompheniramine maleate and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28595-900
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	4 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
Magnesium Stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	300
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28595-900-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/01/2013

Labeler - Allegis Pharmaceuticals, LLC (792272861)