FDA Label for Well At Walgreens Multi-symptom Wal-flu Severe Cold And Nighttime Wal-flu Severe Cold And Cough Kit
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR NIGHTTIME WAL-FLU SEVERE COLD AND COUGH
- ACTIVE INGREDIENTS FOR MULTI-SYMPTOM WAL-FLU SEVERE COLD
- PURPOSE NIGHTTIME
- PURPOSE MULTI-SYMPTOM
- NIGHTTIME WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- INDICATIONS & USAGE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- MULTI-SYMPTOM WARNINGS
- NIGHTTIME DOSAGE AND ADMINISTRATION
- MULTI-SYMPTOM DOSAGE & ADMINISTRATION
- NIGHTTIME INFORMATION FOR PATIENTS
- MULTI-SYMPTOM INFORMATION FOR PATIENTS
- NIGHTTIME INACTIVE INGREDIENT
- MULTI-SYMPTOM INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Well At Walgreens Multi-symptom Wal-flu Severe Cold And Nighttime Wal-flu Severe Cold And Cough Kit Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Do Not Use
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.
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.
Otc - Ask Doctor
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 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.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Indications & Usage
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.
When using this product
- do not exceed recommended dosage.
Otc - Stop Use
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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
Overdosage
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.
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.
Nighttime Dosage And Administration
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and older | one 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
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one 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.
Package Label.Principal Display Panel
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