Aller-chlor by A-S Medication Solutions Rugby 44-194

Aller-chlor by

Drug Labeling and Warnings

Aller-chlor by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLER-CHLOR- chlorpheniramine maleate tablet 
A-S Medication Solutions

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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Rugby 44-194

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

Do not use  

to make a child sleepy. 

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
  
• glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• drowsiness may occur
• avoid alcoholic beverages
• 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 a Poison Control Center (1-800-222-1222) right away.

Directions

• take every 4 to 6 hours, or as directed by a doctor

• adults and children 12 years and over: 1 tablet. Do not exceed ; 6 tablets in 24 hours.
• children 6 to under12 years: 1/2 tablet (break tablet ; in half). Do not exceed ; 3 whole tablets in 24 ; hours.
• children under 6 years: do not use

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from excessive moisture
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-645-2158

HOW SUPPLIED

Product: 50090-2000

Chlorpheniramine Maleate

ALLER-CHLOR 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-2000(NDC: 0536-1006)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;194
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-2000-6	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2015	03/31/2018
2	NDC: 50090-2000-7	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2015	03/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/19/1992	03/31/2018

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2000) , REPACK(50090-2000)

Revised: 1/2020

Document Id: d5ba72c7-2202-4e28-b808-733b507e5d89

34390-5

Set id: d2024ec2-4e15-4b51-9430-50b42b51bd73

Version: 9

Effective Time: 20200118

 

A-S Medication Solutions