WELL AT WALGREENS MULTI-SYMPTOM WAL-FLU SEVERE COLD AND NIGHTTIME WAL-FLU SEVERE COLD AND COUGH KIT- acetaminophen, diphenhydramine hcl, phenylephrine hcl and dextromethorphan hbr 
Walgreen Co.

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.

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Well at Walgreens Multi-Symptom Wal-Flu Severe Cold and Nighttime Wal-Flu Severe Cold & Cough Kit

Active Ingredients for Nighttime Wal-Flu Severe Cold and Cough

Active ingredients (in each packet) Purpose

Acetaminophen 650 mg ........................................Pain reliever/Fever reducer

Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant

Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.

Active Ingredients for Multi-Symptom Wal-Flu Severe Cold

Active ingredients (in each packet) Purpose

Acetaminophen 500 mg ........................................Pain reliever/Fever reducer

Dextromethorphan hydrobromide 20 mg ..............Cough suppressant

Phenylephrine hydrochloride 10 mg.......................Nasal decongestant.

Purpose Nighttime

Uses

- temporarily relieves these symptoms due to a cold:

- minor aches and pains - headache - minor sore throat pain

- nasal and sinus congestion - cough due to minor throat and bronchial irritation

- runny nose - sneezing - itchy, watery eyes due to hay fever

- itchy nose and throat

- temporarily reduces fever.

Purpose Multi-Symptom

Uses

- Temporarily relieves these symptoms due to a cold:

- minor aches and pains - headache - minor sore throat pain

- nasal and sinus congestion - cough due to minor throat and bronchial irritation

- Temporarily reduces fever.

Nighttime Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin 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

- In a child under 4 years of age.

- If you are allergic to Acetaminophen.

- with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

- with any other product containing diphenhydramine, even one used on the skin

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

Ask a doctor before use if you have

- liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

- a sodium restricted diet.

Ask a doctor or pharmacist before use if you are

- taking sedatives or tranquilizers

- taking the blood thinning drug warfarin.

When using this product

- do not exceed recommended dosage

- avoid alcoholic drinks

- marked drowsiness may occur

- 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

- nervousness, dizziness, or sleeplessness occurs

- fever gets worse or lasts more than 3 days

- redness or swelling is present

- new symptoms occur

- symptoms do not get better or worsen

- pain, cough or nasal congestion gets worse or lasts more than 7 days

- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children.

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

Multi-Symptom Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin redenning - blisters - rash. If a skin 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

- In a child under 4 years of age.

- If you are allergic to Acetaminophen.

- with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

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

Ask a doctor before use if you have

- liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

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

When using this product

- do not exceed recommended dosage.

Stop use and ask a doctor if

- nervousness, dizziness, or sleeplessness occurs

- fever gets worse or lasts more than 3 days

- redness or swelling is present

- new symptoms occur

- symptoms do not get better or worsen

- pain, cough or nasal congestion gets worse or lasts more than 7 days

- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children.

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

Nighttime Dosage and Administration

AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and olderone packet

- do not use more than directed.

- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.

- dissolve content of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Multi-Symptom Dosage & Administration

AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and overone packet

- do not use more than directed.

- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.

- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Nighttime Information for Patients

Other information

- each packet contains: potassium 7 mg, sodium 46 mg

- phenylketonurics: contains phenylalanine 13 mg per packet

- store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.

Multi-Symptom Information for Patients

Other information

- each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg.

- phenylketonurics: contains phenylalanine 13 mg per packet

- store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.

Nighttime Inactive Ingredient

Acesulfame potassium, Aspartame, Caramel, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.

Multi-Symptom Inactive Ingredient

Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, Silicon dioxide, Sodium Citrate, Starch and Sucrose.

MM1. jpg

WELL AT WALGREENS MULTI-SYMPTOM WAL-FLU SEVERE COLD AND NIGHTTIME WAL-FLU SEVERE COLD AND COUGH KIT 
acetaminophen, diphenhydramine hcl, phenylephrine hcl and dextromethorphan hbr kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1103
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1103-121 in 1 BOX; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOX
Part 21 BOX
Part 1 of 2
WALGREENS NIGHTTIME WAL-FLU SEVERE COLD AND COUGH  HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS
acetaminophen, diphenhydramine hcl and phenylephrine hcl granule, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Coloryellow (Caramel color) , yellow (D and C Yellow 10) Score    
ShapeSize
FlavorHONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/08/2013
Part 2 of 2
WALGREENS MULTI-SYMPTOM WAL-FLU SEVERE COLD  GREEN TEA AND HONEY LEMON FLAVORS
acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Coloryellow (Caramel color) , yellow (D and C Yellow No. 10) Score    
ShapeSize
FlavorHONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/09/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/11/2015
Labeler - Walgreen Co. (008965063)

Revised: 12/2015
Document Id: 267ace69-bb22-482f-e054-00144ff8d46c
Set id: 1f336dce-df94-4c93-b901-17efc0b899d7
Version: 2
Effective Time: 20151209
 
Walgreen Co.