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Allergy by A-S Medication Solutions

Medically reviewed on Nov 21, 2017

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg
Labeler: A-S Medication Solutions
NDC Code: 50090-0049

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.

Major 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  
  • glaucoma
  • 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
  • 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
adults and children
12 years of age
and over
1 tablet every 4 to 6
hours. Do not take more
than 6 tablets in 24 hours.
children 6 to under
12 years of age
1/2 tablet (break tablet in
half) every 4 to 6 hours.
Do not exceed 3 whole
tablets in 24 hours.
children under 6
years of age
do not use this product in
children under 6 years of
age


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?

(800) 616-2471

HOW SUPPLIED

Product: 50090-0049

NDC: 50090-0049-6 20 TABLET in a BOTTLE

NDC: 50090-0049-7 60 TABLET in a BOTTLE

Chlorpheniramine Maleate
ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0049(NDC:0904-0012)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code44;194
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-0049-620 TABLET in 1 BOTTLE
2NDC:50090-0049-760 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/1992
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0049), REPACK(50090-0049)

 
A-S Medication Solutions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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