OTC Medication Information: Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold (Page 2 of 2)

Directions

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Other information

Other information

● store at room temperature. Avoid temperatures above 25°C (77°F).

Inactive ingredients FD&C Blue #1, FD&C yellow
#10, gelatin, glycerin, potassium aluminum silicate, polyethylene glycol ,
povidone, propylene glycol, purified water, sorbitol
sorbitan solution, titanium dioxide

Questions or comments?

Questions or comments? 1-888-333-9792

Principal Display Panel

Walgreens Maximum Strength Day & Night Sinus & Cold

Compare to the active ingredients in
Alka-Seltzer PLUS® Maximum Strength Day
and Night Sinus & Cold POWERMAX™ GELS

DAY NON DROWSY

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves:

Nasal Congestion
Headache & Body Ache
Cough
Sore Throat
Sinus Pressure

16 SOFTGELS

NIGHT TIME

Acetaminophen / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

Nasal Congestion
Headache & Body Ache
Cough
Runny Nose
Sore Throat
8 SOFTGELS

24 SOFTGELS TOTAL

*This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Alka-Seltzer PLUS® POWERMAX™ GELS.

image descriptionimage description
WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD walgreens maximum strength non-drowsy day and night sinus and cold kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5551
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-5551-24 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 BLISTER PACK 16
Part 2 1 BLISTER PACK 8 in 2
Part 1 of 2
MAXIMUM STRENGTH NON DROWSY DAYTIME SINUS AND COLD acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
SORBITAN
SORBITOL
TITANIUM DIOXIDE
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
WATER
POVIDONE
POTASSIUM ALUMINUM DISILICATE
Product Characteristics
Color orange (Opaque) Score no score
Shape OVAL (oblong) Size 18mm
Flavor Imprint Code 101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/20/2019
Part 2 of 2
MAXIMUM STRENGTH NIGHTTIME SINUS AND COLD acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE
FD&C BLUE NO. 1
SORBITOL
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 400
POVIDONE
D&C YELLOW NO. 10
SORBITAN
POTASSIUM ALUMINUM DISILICATE
Product Characteristics
Color green (opaque) Score no score
Shape OVAL (oblong) Size 19mm
Flavor Imprint Code 102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/20/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/20/2019
Labeler — Walgreens (008965063)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
MEDGEL PVT LTD 677385498 manufacture (0363-5551)

Revised: 02/2020 Walgreens

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Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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