Daytime Non Drowsy Severe Cold & Flu And Nighttime Severe Cold & Flu (combo Pack)

Daytime Non Drowsy Severe Cold & Flu And Nighttime Severe Cold & Flu (combo Pack)
SPL v6
SPL
SPL Set ID 2dba2bec-e0e3-4910-89c5-ebc093e05bec
Route
ORAL
Published
Effective Date 2021-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Guaifenesin (200 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide Fd&c Yellow No. 6 Sodium Hydroxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 116;A07 Shape: oval Color: orange Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-23 Until 2027-06-30

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Description

Drug Facts

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ minor aches & pains ■ headache

■ fever ■ sore throat ■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ helps loosen phlegm (mucus) and thin bronchial secretions to

rid the bronchial passageways of bothersome mucus and make

coughs more productive.

Section 42229-5

Drug Facts (continued)

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

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

thinning drug warfarin.

Section 53414-9

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

Section 55105-1

Active ingredients (in each softgel)                                Purposes

Acetaminophen 325 mg............................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.............................Cough suppressant

Guaifenesin 200 mg.........................................................Expectorant

Phenylephrine HCl 5 mg......................................Nasal decongestant

Section 55106-9

Drug Facts

Warnings

Liver warning This product contains acetaminophen. Severe liver

damage may occur if you take

■ more than 4 doses in 24 hours, which is the maximum daily

amount for this product

■ with other drugs containing acetaminophen

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

Directions

■ take only as directed - see Overdose warning

■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over  2 softgels with water every

4 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use

■ when using other Nighttime or Daytime products, carefully read

each label to ensure correct dosing

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.

Overdose Warning

Taking more than directed can cause serious

health problems. 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.

Other Information

■ store at room temperature

Inactive Ingredients

FD&C Yellow # 6, gelatin, glycerin,

polyethylene glycol, povidone, propylene glycol, purified water,

sorbitol sorbitan , titanium dioxide

Questions Or Comments?

Call toll free: 1-888-333-9792

Principal Display Panel

DAY & NIGHT PACK

Walgreens

Compare to Vicks® DayQuil® Severe



Cold & Flu & Vicks® NyQuil® Severe



Cold & Flu active ingredients††

DAYTIME • NON-DROWSY

Severe



Cold & Flu



ACETAMINOPHEN /



PAIN RELIEVER / FEVER REDUCER



DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT



GUAIFENESIN / EXPECTORANT



PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

16 SOFTGELS

NIGHTTIME

Severe



Cold & Flu



ACETAMINOPHEN /



PAIN RELIEVER / FEVER REDUCER



DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT



DOXYLAMINE SUCCINATE / ANTIHISTAMINE



PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

8 SOFTGELS

24 SOFTGELS

When Using This Product

■ do not use more than directed

■ excitability may occur, especially in children

■ marked drowsiness may occur ■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Daytime Severe Cold and Flu

Stop Use and Ask A Doctor If

■ you get nervous, dizzy or sleepless

■ pain, nasal congestion, or cough 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.

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema

Nighttime Severe Cold & Flu Softgels

Drug Facts (continued)

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin


Structured Label Content

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ minor aches & pains ■ headache

■ fever ■ sore throat ■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ helps loosen phlegm (mucus) and thin bronchial secretions to

rid the bronchial passageways of bothersome mucus and make

coughs more productive.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts (continued)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

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

thinning drug warfarin.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each softgel)                                Purposes

Acetaminophen 325 mg............................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.............................Cough suppressant

Guaifenesin 200 mg.........................................................Expectorant

Phenylephrine HCl 5 mg......................................Nasal decongestant

Section 55106-9 (55106-9)

Drug Facts

Warnings

Liver warning This product contains acetaminophen. Severe liver

damage may occur if you take

■ more than 4 doses in 24 hours, which is the maximum daily

amount for this product

■ with other drugs containing acetaminophen

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

Directions

■ take only as directed - see Overdose warning

■ do not exceed 4 doses per 24 hours

 adults & children 12 years & over  2 softgels with water every

4 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use

■ when using other Nighttime or Daytime products, carefully read

each label to ensure correct dosing

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.

Overdose Warning (Overdose warning)

Taking more than directed can cause serious

health problems. 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.

Other Information (Other information)

■ store at room temperature

Inactive Ingredients (Inactive ingredients)

FD&C Yellow # 6, gelatin, glycerin,

polyethylene glycol, povidone, propylene glycol, purified water,

sorbitol sorbitan , titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free: 1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DAY & NIGHT PACK

Walgreens

Compare to Vicks® DayQuil® Severe



Cold & Flu & Vicks® NyQuil® Severe



Cold & Flu active ingredients††

DAYTIME • NON-DROWSY

Severe



Cold & Flu



ACETAMINOPHEN /



PAIN RELIEVER / FEVER REDUCER



DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT



GUAIFENESIN / EXPECTORANT



PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

16 SOFTGELS

NIGHTTIME

Severe



Cold & Flu



ACETAMINOPHEN /



PAIN RELIEVER / FEVER REDUCER



DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT



DOXYLAMINE SUCCINATE / ANTIHISTAMINE



PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

8 SOFTGELS

24 SOFTGELS

When Using This Product (When using this product)

■ do not use more than directed

■ excitability may occur, especially in children

■ marked drowsiness may occur ■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Daytime Severe Cold and Flu (DAYTIME SEVERE COLD AND FLU)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ you get nervous, dizzy or sleepless

■ pain, nasal congestion, or cough 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ liver disease ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema

Nighttime Severe Cold & Flu Softgels (NIGHTTIME SEVERE COLD & FLU SOFTGELS)

Drug Facts (continued)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin


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Raw Label Data

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