630t Cvs 69842-442 Maximum Strength Daytime Nighttime Sinus Relief

630t Cvs 69842-442 Maximum Strength Daytime Nighttime Sinus Relief
SPL v3
SPL
SPL Set ID c17d5ba7-3302-7931-e053-2a95a90a5a6c
Route
ORAL
Published
Effective Date 2021-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 116 Shape: oval Shape: capsule 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 Sinus Relief Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) Nighttime Sinus Relief Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCI 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

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.

Indications and Usage

Uses

  • temporarily relieves:

cough

minor aches and pains

headache

nasal congestion

sinus congestion and pressure

runny nose and sneezing ( 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 )
  • temporarily promotes nasal and/or sinus drainage

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 older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
Description

Active ingredients (in each softgel) Daytime Sinus Relief Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Active ingredients (in each softgel) Nighttime Sinus Relief Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCI 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

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 Sinus Relief

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Nighttime Sinus Relief

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each softgel)

Daytime Sinus Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel)

Nighttime Sinus Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 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:

cough

minor aches and pains

headache

nasal congestion

sinus congestion and pressure

runny nose and sneezing ( 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 )
  • temporarily promotes nasal and/or sinus drainage

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 older: 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

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.

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)

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 Sinus Relief

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Purposes

Nighttime Sinus Relief

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each softgel)

Daytime Sinus Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each softgel)

Nighttime Sinus Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:33.374533 · Updated: 2026-03-14T23:07:34.278056