Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu: Package Insert and Label Information

WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU-
Walgreens

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.

Do not take these products at the same time.

Drug Facts

Walgreens Non Drowsy Day Cold & Flu

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than

2 days, is accompanied or followed by fever, headache, rash, nausea,

or vomiting, consult a doctor promptly.

Do not use

● with any other drug containing acetaminophen (prescription or

nonprescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

● if you are now taking a prescription monoamine oxidase inhibitor

(MAOI) (certain drugs for depression, psychiatric, or emotional

conditions, or Parkinson’s disease), or for 2 weeks after stopping

the MAOI drug. If you do not know if your prescription drug contains

an MAOI, ask a doctor or pharmacist before taking this product.

● if you have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfa

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

· pain, cough, or nasal congestion gets worse or lasts more than

7 days

· fever gets worse or lasts more than 3 days

· redness or swelling is present

· new symptoms occur

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 yellow #6, gelatin,
glycerin, potassium aluminum silicate, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol , titanium
dioxide

Questions or comments?

Questions or comments? 1-888-333-9792

Walgreens Maximum Strength Night Cold & Flu

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache

· nasal and sinus congestion · cough · sore throat

· runny nose · sneezing

· temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than

2 days, is accompanied or followed by fever, headache, rash, nausea,

or vomiting, consult a doctor promptly.

Do not use to sedate children.

Do not use

● with any other drug containing acetaminophen (prescription or

nonprescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

● if you are now taking a prescription monoamine oxidase inhibitor

(MAOI) (certain drugs for depression, psychiatric, or emotional

conditions, or Parkinson’s disease), or for 2 weeks after stopping

the MAOI drug. If you do not know if your prescription drug contains

an MAOI, ask a doctor or pharmacist before taking this product.

● if you have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes ● glaucoma

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

● may cause marked drowsiness

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Stop use and ask a doctor if

· pain, cough, or nasal congestion gets worse or lasts more than

7 days

· fever gets worse or lasts more than 3 days

· redness or swelling is present

· new symptoms occur

· cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

PRINCIPLA DISPLAY PANEL

Walgreens Maximum Strength Day & Night Cold & Flu

Compare to the active ingredients in
Alka-Seltzer PLUS® Maximum Strength Day
and Night Cold & Flu 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 COLD AND FLU walgreens maximum strength non drowsy day and night cold and flu kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5552
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-5552-24 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 COLD AND FLU 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 02/04/2020
Part 2 of 2
MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 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 02/04/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/04/2020
Labeler — Walgreens (008965063)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
MEDGEL PVT LTD 677385498 manufacture (0363-5552)

Revised: 04/2020 Walgreens

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