CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet 
Clinical Solutions Wholesale

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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Aller·chlor®

Active Ingredient

(in each tablet)

Chlorpheniramine Maleate 4 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

•
runny nose
•
itchy nose or throat
•
sneezing
•
itchy, watery eyes

WARNINGS

Ask a doctor before use if you have

•
glaucoma
•
a breathing problem such as emphysema or chronic bronchitis
•
trouble urinating due to an enlarged prostate gland

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

When using this product

•
you may get drowsy
•
avoid alcoholic drinks
•
alcohol, sedatives & tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating a machine
•
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 a Poison Control Center right away.

Directions

•
take every 4-6 hours
•
do not take more than 6 doses in 24 hours
Adults & children 12 years and over 1 tablet

Children 6 to under 12 years

½ tablet

Children under 6 years

do not use

Other Information

•
each tablet contains: calcium 40 mg
•
store between 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

* Rugby Laboratories, Inc. is not affiliated with the owner of the trademark Chlor-Trimeton®. Aller·chlor® is distributed by Rugby Laboratories, Inc.

Rugby® Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aller4Lab3

Principal Display Panel

Aller4Lab6

Principal Display Panel

Aller4Lab9
CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58118-3467(NDC:0536-3467)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SILICON DIOXIDE 
Product Characteristics
ColorYELLOW (light yellow) Score2 pieces
ShapeROUNDSize8mm
FlavorImprint Code AP;016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58118-3467-330 in 1 BOTTLE
2NDC:58118-3467-660 in 1 BOTTLE
3NDC:58118-3467-990 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/30/2000
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIBusiness Operations
Clinical Solutions Wholesale078710347REPACK(58118-3467), RELABEL(58118-3467)

Revised: 11/2013
Document Id: 65312118-6067-459c-905d-08aaf6db5710
Set id: 65312118-6067-459c-905d-08aaf6db5710
Version: 1
Effective Time: 20131111
 
Clinical Solutions Wholesale