Walgreens Non-drowsy Daytime & Nighttime Cold And Flu

Walgreens Non-drowsy Daytime & Nighttime Cold And Flu
SPL v2
SPL
SPL Set ID 3e8473be-ce6e-4ebe-9ae9-a255c0745397
Route
ORAL
Published
Effective Date 2020-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol 400 Titanium Dioxide Povidone K30 Propylene Glycol Sorbitol Gelatin Water D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 215 Shape: capsule Shape: oval Color: red Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-02-06

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • fever
    • headache
    • sore throat
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)
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 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
  • 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
  • to make a child sleepy (Nighttime only)
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number
Questions Or Comments?

1-888-333-9792

Principal Display Panel

DAY & NIGHT PACK





Walgreens

Compare to Vicks® DayQuil® &

NyQuil® Cold & Flu LiquiCaps®

active ingredients ††

DAYTIME • NON DROWSY

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL

SIZE

16

LIQUID

CAPS

NIGHTTIME

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT 

DOXYLAMINE SUCCINATE /

ANTIHISTAMINE

MULTI-SYMPTOM

ACTUAL

SIZE

8

LIQUID 

CAPS

24 TOTAL LIQUID CAPS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or

distributed by Procter & Gamble, owner of the

registered trademark Vicks® DayQuil® &

NyQuil® Cold & Flu LiquiCaps®.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
Directions (daytime Only)
  • do not take more than directed
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 4 hours
  • children under 12 years: ask a doctor
Directions (nighttime Only)
  • do not take more than directed

  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 6 hours
  • children under 12 years: ask a doctor
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
  • pain or cough gets worse or lasts more than 7 days  (Nighttime only)
  • 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • glaucoma (Nighttime only)
Inactive Ingredients (daytime Only)

FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene

glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,

titanium dioxide

Inactive Ingredients (nighttime Only)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene

glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,

titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Liquid Filled Capsule) 

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Liquid Filled Capsule) (nighttime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • fever
    • headache
    • sore throat
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 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 (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
  • to make a child sleepy (Nighttime only)
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number
Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

DAY & NIGHT PACK





Walgreens

Compare to Vicks® DayQuil® &

NyQuil® Cold & Flu LiquiCaps®

active ingredients ††

DAYTIME • NON DROWSY

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL

SIZE

16

LIQUID

CAPS

NIGHTTIME

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT 

DOXYLAMINE SUCCINATE /

ANTIHISTAMINE

MULTI-SYMPTOM

ACTUAL

SIZE

8

LIQUID 

CAPS

24 TOTAL LIQUID CAPS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or

distributed by Procter & Gamble, owner of the

registered trademark Vicks® DayQuil® &

NyQuil® Cold & Flu LiquiCaps®.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
Directions (daytime Only) (Directions (Daytime only))
  • do not take more than directed
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 4 hours
  • children under 12 years: ask a doctor
Directions (nighttime Only) (Directions (Nighttime only))
  • do not take more than directed

  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 6 hours
  • children under 12 years: ask a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
  • pain or cough gets worse or lasts more than 7 days  (Nighttime only)
  • 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • glaucoma (Nighttime only)
Inactive Ingredients (daytime Only) (Inactive ingredients (Daytime only))

FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene

glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,

titanium dioxide

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene

glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,

titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Liquid Filled Capsule)  (Active ingredients (in each liquid-filled capsule) )

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Liquid Filled Capsule) (nighttime Cold & Flu) (Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


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