Family Wellness 44-194

Drug Labeling and Warnings

Drug Details [pdf]

ALLERGY RELIEF- chlorpheniramine maleate tablet 
Family Dollar Services 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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Family Wellness 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

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


  • 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 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

Principal Display Panel

FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT IN CHLOR-TRIMETON® ALLERGY TABLETS*

Allergy Relief
Chlorpheniramine maleate 4 mg
4 - Hour Antihistamine
For Relief of Sneezing,
Runny Nose, Itchy Throat
and Itchy, Watery Eyes

24 TABLETS

*This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Chlor-Trimeton®.
50844    REV0512A19408

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD, MATTHEWS, NC 28105 USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Family Wellness 44-194

Family Wellness 44-194

ALLERGY RELIEF 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-194
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-194-082 in 1 CARTON12/19/199207/08/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/199207/08/2019
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55319-194)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55319-194)

Revised: 8/2016
Document Id: dcfef89c-6cc1-40b7-bc25-551da95e8733
Set id: 94a25dc4-fcad-40c7-9b1b-552398540e1f
Version: 7
Effective Time: 20160805