PSEUDOEPHEDRINE PLUS- pseudoephedrine hydrochloride chlorpherniamine maleate tablet
Contract Pharmacal Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1016

Drug Facts

Active Ingredient

(in each tablet)
Pseudoephedrine Hydrochloride 30 mg
Chlorpheniramine Maleate 4 mg

Purposes

Nasal Decongestant
Antihistamine

Uses

temporarily relieves these symptoms due to hay fever and the common cold
itching of the nose and throat,
sneezing
runny nose
itchy, watery eyes
nasal congestion

Warnings

Do not use

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 are uncertain whether your prescription drug contains an MAOI

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
difficulty in urination due to enlargement of the prostate gland

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

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever

When using this product

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

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 Poison Control Center right away.

Directions

adults and children 12 years of age and over	take 1 tablet every 4 to 6 hours, not to exceed 4 doses in 24 hours
children 6 to 12 years of age	take ½ tablet every 4 to 6 hours, not to exceed 4 doses in 24 hours
children under 6 years of age	consult a physician

DO NOT EXCEED RECOMMENDED DOSE

Other information

store at room temperature (59˚ – 86˚F)

Inactive Ingredients

Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone and Magnesium Silicate.

*This product is not manufactured or distributed by Warner-Lambert Consumer, owner of the registered trademark Sudafed® Cold and Allergy Tablets.

Manufactured by:
CONTRACT PHARMACAL CORP.,
Hauppauge, NY 11788 USA
www.CPCHealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PSEUDOEPHEDRINE PLUS
pseudoephedrine hydrochloride chlorpherniamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-1016
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	1016;1016
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-1016-8	1 in 1 CARTON	02/20/2001	12/31/2011
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:10267-1016-7	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2001	12/31/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/20/2001	12/31/2011

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-1016)

Revised: 10/2017

Document Id: 5be8b53e-f3b2-edd8-e053-2a91aa0aa0cb

Set id: 5148515c-88d0-4b13-9c04-ff7ff83e43d1

Version: 3

Effective Time: 20171019

Contract Pharmacal Corp.