NDC Code(s) : 51467-005-01, 51467-005-02
Packager : FORTUNE PHARMACAL COMPANY LIMITED

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51467-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U) 		CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color orange Score no score
Shape ROUND Size 12 mm
Flavor Imprint Code COLTALIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51467-005-012 in 1 BOX 03/01/2004
112 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:51467-005-023 in 1 BOX 26/04/2016
212 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M 03/01/2004

LABELER - FORTUNE PHARMACAL COMPANY LIMITED(686280561)

REGISTRANT - FORTUNE PHARMACAL COMPANY LIMITED(686280561)

Establishment
Name Address ID/FEI Business Operations
FORTUNE PHARMACAL COMPANY LIMITED 686280561 manufacture(51467-005)

PRINCIPAL DISPLAY PANEL

COLTALIN

Safely Sealed

NDC 51467-005-01

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

24 Tablets

In Individually Sealed Strip

Aspirin Free
IMAGE OF 24 TABLETS BOX

PRINCIPAL DISPLAY PANEL

COLTALIN

Safely Sealed

NDC 51467-005-02

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

36 Tablets

In Individually Sealed Strip

Aspirin Free
IMAGE OF 36 TABLETS BOX