Allergy by A-S Medication Solutions Major 44-194

Allergy by

Drug Labeling and Warnings

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

Drug Details [pdf]

ALLERGY- 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.

----------

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
  • difficulty in urination due to enlargement of the 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

  • 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 under 12
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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

Chlorpheniramine Maleate

Label Image
ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-0049(NDC: 0904-0012)
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
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
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-0049-760 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201406/30/2019
2NDC: 50090-0049-620 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201404/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/199206/30/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0049) , REPACK(50090-0049)

Revised: 1/2020
Document Id: 42603e07-0bb1-49dc-951f-93186a4cdabb
Set id: b199b5ee-fff3-4746-be68-a04060586f8e
Version: 7
Effective Time: 20200117
 
A-S Medication Solutions