ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride tablet

ACTICON by

Drug Labeling and Warnings

ACTICON by is a Otc medication manufactured, distributed, or labeled by Actipharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Dexbrompheniramine Maleate, USP 2 mg

Pseudoephedrine HCl, USP 60 mg

Purpose

Antihistamine

Nasal Decongestant

Keep out of reach of children.

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

INDICATIONS & USAGE

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.

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours not to exceed 4 tablets in 24 hours or as directed by a doctor
• Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours not to exceed 2 tablets in 24 hours or as directed by a doctor
• Children under 6 years of age: Consult a doctor

Inactive ingredients

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Other information

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

Questions or Comments?

Call 787-608-0882

SPL UNCLASSIFIED SECTION

Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787) 608-0882

*Conex® Tablets is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Contains the same active ingredients as Conex® Tablets*

ANTIHISTAMINE  NASAL DECONGESTANT

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Packaging

INGREDIENTS AND APPEARANCE

ACTICON 
dexbrompheniramine maleate, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	A401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-401-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/13/2015

Labeler - Actipharma, Inc (079340948)