NDC Code(s) : 10202-445-91
Packager : 7-Eleven

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

7 Select Night Time severe cold, cough and fluAcetaminophen, diphenhydramine HCl, phenylephrine HCl POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10202-445
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
Product Characteristics
Color WHITE, YELLOW (Light to dark) Score
Shape Size
Flavor HONEY, LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10202-445-916 in 1 CARTON Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/12/2015

PRINCIPAL DISPLAY PANEL

Compare to Theraflu® Severe Cold & Cough active ingredients

Night Time Severe Cold, Cough & Flu

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Alcohol-free

Nasal Congestion

Cough / Runny Nose / Sneezing

Body Ache / Headache / Fever

Sore Throat Pain

Honey Lemon Infused with White Tea Flavors

6 Packets

7 Select Night Time Severe Cold, Cough & flu image 17 Select Night Time Severe Cold, Cough & flu image 1