Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-1103-12 - Packager: Walgreen Co.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 9, 2015
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- Active Ingredients for Nighttime Wal-Flu Severe Cold and Cough
- Active Ingredients for Multi-Symptom Wal-Flu Severe Cold
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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
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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. -
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. -
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.
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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
- Multi-Symptom Information for Patients
- Nighttime Inactive Ingredient
- Multi-Symptom Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
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 kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1103 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1103-12 1 in 1 BOX; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOX 6 Part 2 1 BOX 6 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 solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Product Characteristics Color yellow (Caramel color) , yellow (D and C Yellow 10) Score Shape Size Flavor HONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 BOX; 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 10/08/2013 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 solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength 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 Color yellow (Caramel color) , yellow (D and C Yellow No. 10) Score Shape Size Flavor HONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 BOX; 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 06/09/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/11/2015 Labeler - Walgreen Co. (008965063)