630t Cvs 69842-451 Maximum Strength Daytime Nighttime Cold And Flu

630t Cvs 69842-451 Maximum Strength Daytime Nighttime Cold And Flu
SPL v3
SPL
SPL Set ID c17b8f17-95f6-37e4-e053-2995a90a411a
Route
ORAL
Published
Effective Date 2021-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Aluminum Lake Sorbitol Povidone Polyethylene Glycol, Unspecified Propylene Glycol Water Shellac Titanium Dioxide Gelatin Glycerin Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 72 Shape: oval Color: orange Color: green Size: 24 mm Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-10

Description

Active ingredients (in each softgel) Daytime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) Nighttime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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.

Indications and Usage

Uses

  • temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure

cough

minor aches and pains

headache

nasal congestion

sore throat

runny nose and sneezing ( Nighttime only )

itchy, watery eyes due to hay fever ( Nighttime only )

itching of the nose or throat ( Nighttime only )

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ( Daytime only )
  • controls cough to help you get to sleep
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and over: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
Description

Active ingredients (in each softgel) Daytime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) Nighttime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Section 50565-1

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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 fever, rash, or headache that lasts.

These could be signs of a serious condition.

Section 50567-7

When using this product

  • do not use more than directed
  • excitability may occur, especially in children ( Nighttime only )
  • marked drowsiness may occur ( Nighttime only )
  • alcohol, sedatives, and tranquilizers may increase drowsiness ( Nighttime only )
  • avoid alcoholic drinks ( Nighttime only )
  • be careful when driving a motor vehicle or operating machinery ( Nighttime only )
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers ( Nighttime only )
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma ( Nighttime only )
  • breathing problems such as emphysema or chronic bronchitis ( Nighttime only )
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1

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.
Section 51727-6

Inactive ingredients (Daytime only)

FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Inactive ingredients (Nighttime only)

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Section 51945-4

Section 53413-1

Questions? call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purposes

Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each softgel)

Daytime Cold & Flu

Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel)

Nighttime Cold & Flu


Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Other Information

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure

cough

minor aches and pains

headache

nasal congestion

sore throat

runny nose and sneezing ( Nighttime only )

itchy, watery eyes due to hay fever ( Nighttime only )

itching of the nose or throat ( Nighttime only )

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ( Daytime only )
  • controls cough to help you get to sleep
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and over: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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 fever, rash, or headache that lasts.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • excitability may occur, especially in children ( Nighttime only )
  • marked drowsiness may occur ( Nighttime only )
  • alcohol, sedatives, and tranquilizers may increase drowsiness ( Nighttime only )
  • avoid alcoholic drinks ( Nighttime only )
  • be careful when driving a motor vehicle or operating machinery ( Nighttime only )
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers ( Nighttime only )
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma ( Nighttime only )
  • breathing problems such as emphysema or chronic bronchitis ( Nighttime only )
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients (Daytime only)

FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Inactive ingredients (Nighttime only)

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each softgel)

Daytime Cold & Flu

Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel)

Nighttime Cold & Flu


Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Other Information (OTHER INFORMATION)

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

Advanced Ingredient Data


Raw Label Data

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