Cold & Flu Nighttime Severe, 24/7 Life By 7-eleven

Cold & Flu Nighttime Severe, 24/7 Life By 7-eleven
SPL v2
SPL
SPL Set ID 05d0410f-164e-e7ee-e063-6394a90a2aaa
Route
ORAL
Published
Effective Date 2022-04-19
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
Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake Starch, Corn Crospovidone, Unspecified Talc Ferrosoferric Oxide Fd&c Yellow No. 6 Sodium Starch Glycolate Type A Potato Stearic Acid Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Magnesium Stearate Povidone, Unspecified Polysorbate 80 Titanium Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 44;677 Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-19

Description

Drug Facts

Purpose

​Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Drug Facts

Uses

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
  • cough to help you sleep
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Warnings

​Warnings

Directions

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

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
Drug Facts

Drug Facts

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.

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

Other information

  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredients

Active Ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Sore Throat Warning

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.

Inactive Ingredients

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? 1-877-507-6516

Ask A Doctor Before Use

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)
When Using This Product

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
Stop Use and Ask A Doctor

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 presen
  • 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 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.

Ask A Doctor Or Pharmacist Before Use If

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Cold & Flu Nighttime Severe, 16ct, 24/7 Life Pdp/package

[24/7 Life logo]

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 Vicks ® NyQuil ®

VapoCOOL™ SEVERE Cold &

Flu + Congestion
active ingredients*

16

CAPLETS

Actual Size [caplet image]


Structured Label Content

Uses

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
  • cough to help you sleep
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

​Warnings

Directions

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 (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
Drug Facts

Drug Facts

Allergy Alert (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.

Liver Warning (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 (Other information)

Other information

  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredients

Active Ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Sore Throat Warning (Sore throat warning)

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.

Inactive Ingredients (Inactive ingredients)

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?)

Questions or comments? 1-877-507-6516

Ask A Doctor Before Use (Ask a doctor before use)

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)
When Using This Product (When using this product)

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

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 presen
  • 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)

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

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

Keep out of reach of children. 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.

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Cold & Flu Nighttime Severe, 16ct, 24/7 Life Pdp/package (Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package)

[24/7 Life logo]

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 Vicks ® NyQuil ®

VapoCOOL™ SEVERE Cold &

Flu + Congestion
active ingredients*

16

CAPLETS

Actual Size [caplet image]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)