24/7 Life Cold & Flu Nighttime Severe- (7-eleven)

24/7 Life Cold & Flu Nighttime Severe- (7-eleven)
SPL v3
SPL
SPL Set ID ef6836fa-d104-d7b3-e053-2a95a90af2b8
Route
ORAL
Published
Effective Date 2022-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
Polyvinyl Alcohol, Unspecified Titanium Dioxide Talc Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Ferrosoferric Oxide Stearic Acid Polysorbate 80 Povidone, Unspecified Crospovidone D&c Yellow No. 10 Aluminum Lake Starch, Corn Polyethylene Glycol, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 44;677 Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-27

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
  • sore throat
  • fever
  • headache
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Section 42229-5

Satisfaction Guaranteed 1-800-255-0711

*This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks®, NyQuil®, and VapoCool™ are trademarks of The Procter & Gamble Company.

Distributed by: 7-Eleven, Inc., Irving, TX 75063 www.7-ELEVEN.com

Directions
  • do not take more than directed
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
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
6 Count Carton

24/7 Life by 7-Eleven

Cold & Flu

Nighttime

Severe


Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

Relieves: Headache, Fever,

Sore Throat, Minor Aches &

Pains, Nasal Congestion, Sinus

Pressure, Sneezing, Runny Nose,

Cough

compare to V icks® NyQuil®

VapoCOOL™ SEVERE Cold &

Flu + Congestion
active ingredients*

6

CAPLETS

[caplet image]

Actual Size

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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.

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
Other Information

each caplet contains: sodium 3 mg

store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

see end flap for expiration date and lot number

Inactive Ingredients

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-351-2000 (8:30 AM - 5:00 PM CST)

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • 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.
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.

Active Ingredients (in Each Tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • diabetes
  • thyroid disease
  • heart disease
  • glaucoma
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
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
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
  • sore throat
  • fever
  • headache
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Section 42229-5 (42229-5)

Satisfaction Guaranteed 1-800-255-0711

*This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks®, NyQuil®, and VapoCool™ are trademarks of The Procter & Gamble Company.

Distributed by: 7-Eleven, Inc., Irving, TX 75063 www.7-ELEVEN.com

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
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
6 Count Carton

24/7 Life by 7-Eleven

Cold & Flu

Nighttime

Severe


Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine HCl / Nasal Decongestant

Relieves: Headache, Fever,

Sore Throat, Minor Aches &

Pains, Nasal Congestion, Sinus

Pressure, Sneezing, Runny Nose,

Cough

compare to V icks® NyQuil®

VapoCOOL™ SEVERE Cold &

Flu + Congestion
active ingredients*

6

CAPLETS

[caplet image]

Actual Size

Allergy Alert: (Allergy alert:)

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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.

Liver Warning: (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
Other Information

each caplet contains: sodium 3 mg

store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

see end flap for expiration date and lot number

Inactive Ingredients

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or Comments?)

1-800-351-2000 (8:30 AM - 5:00 PM CST)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • 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.
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.

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

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

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Advanced Ingredient Data


Raw Label Data

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