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

Chlorpheniramine Maleate by

Drug Labeling and Warnings

Chlorpheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

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

C:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\figure1.png

Aller Chlor

Chlorpheniramine Maleate 4 mg

24 Tablets

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (light yellow) Score2 pieces
ShapeROUNDSize8mm
FlavorImprint Code AP;016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-3467-3524 in 1 BOTTLE; Type 0: Not a Combination Product05/30/200001/21/2018
2NDC: 0536-3467-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/200007/29/2018
3NDC: 0536-3467-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/200001/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/30/200007/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
 
Rugby Laboratories Inc.