Chlorpheniramine Maleate by Rugby Laboratories Inc. / Advance Pharmaceutical Inc. Aller·chlor®

Drug Details [pdf]

CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet
Rugby Laboratories Inc.

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

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Aller Chlor

Chlorpheniramine Maleate 4 mg

24 Tablets

CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-3467
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW (light yellow)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;016
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0536-3467-35	24 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2000	01/21/2018
2	NDC: 0536-3467-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2000	07/29/2018
3	NDC: 0536-3467-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2000	01/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/30/2000	07/29/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: e7a2920e-33a7-4c97-b26f-a985bef7106b

Set id: db3b283d-1319-4aaa-a1a9-1eb86efb5394

Version: 4

Effective Time: 20191218

Rugby Laboratories Inc.