Chlorpheniramine maleate 4 mg tablet

How supplied

Product: 71335-0963

NDC: 71335-0963-1 30 TABLET in a BOTTLE

NDC: 71335-0963-2 60 TABLET in a BOTTLE

NDC: 71335-0963-3 100 TABLET in a BOTTLE

NDC: 71335-0963-4 120 TABLET in a BOTTLE

NDC: 71335-0963-5 40 TABLET in a BOTTLE

Ingredients and appearance - Product information

Chlorpheniramine maleate 4 mg tablet- Chlorpheniramine maleate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 71335-0963
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorpheniramine maleate ( UNII: V1Q0O9OJ9Z)( Chlorpheniramine - UNII: 3U6IO1965U ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Croscarmellose sodium ( UNII: M28OL1HH48)
Anhydrous dibasic calcium phosphate ( UNII: L11K75P92J)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)

Product Characteristics

Imprint Code AP;016 Score 1
Size 8 mm Color yellow
Shape ROUND

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 71335-0963-1 30 in 1 BOTTLE 2018/10/09
2 NDC: 71335-0963-2 60 in 1 BOTTLE 2018/10/09
3 NDC: 71335-0963-3 100 in 1 BOTTLE 2018/10/09
4 NDC: 71335-0963-4 120 in 1 BOTTLE 2018/10/09
5 NDC: 71335-0963-5 40 in 1 BOTTLE 2018/10/09

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA 2018/10/09

Labeler - Bryant Ranch Prepack( 171714327)

Establishment

Name ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK( 71335-0963), RELABEL( 71335-0963)

Chlorpheniramine maleate 4 mg (chlorpheniramine maleate) tablet