ANTI ALLERGY- chlorpheniramine maleate tablet 
Advance Pharmaceutical 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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Anti-Allergy Tablets Antihistamine

Active Ingredient

(in each tablet)

Chlorpheniramine Maleate 4 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies :

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions[/S]

Adults & children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Other Information

Inactive Ingredients

croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

Questions or Comments

Call 1-800-645-2158, 8.30 am – 4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

93a742c3-figure-01

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Chlorpheniramine Maleate 4 mg
Antihistamine

17714-016-01  100 Tablets

ANTI ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-016
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)  
CELLULOSE, MICROCRYSTALLINE (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:17714-016-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/09/2002
2NDC:17714-016-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/09/2002
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-016)

Revised: 10/2017
Document Id: 5cc9196c-68c7-c9c1-e053-2a91aa0acd8b
Set id: 6fb948b3-cf48-4503-921e-e8279f2e95f8
Version: 2
Effective Time: 20171030
 
Advance Pharmaceutical Inc.