Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID d5671a70-8376-4d4e-b29a-21b365eb857a

Route

ORAL

Published

Effective Date 2024-03-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-30

Description

Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg

Purpose

Pain Reliever Antihistamine / cough suppressant Nasal decongestant

Medication Information

Purpose

Pain Reliever Antihistamine / cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Uses

temporarily relieves
- nasal congestion
- headache
- minor aches and pains
- cough
- sinus congestion and pressure
- runny nose and sneezing
- temporarily promotes nasal and/or sinus drainage
- controls cough to help you get to sleep

Purposes

Pain Reliever

Antihistamine / cough suppressant

Nasal decongestant

Warnings

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

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

Directions

do not take more than directed (see overdose warning)
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
mL = milliliter
keep dosing cup with product
dose as follows or as directed by a doctor
adults and children 12 years and older:
- 20 mL every 4 hours while symptoms last
children under 12 years of age: do not use

Do Not Use

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist.
with any other drug containing diphenhydramine, even one used on the skin
for children under 12 years of age

Package Label

CVS HEALTH Nighttime Severe Congestion Relief

Other Information

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68º-77ºF). Do not refrigerate.

Inactive Ingredients

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sodium citrate, xanthan gum

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX Night Time Congestion & Cough*

Nighttime

Severe Cough & Congestion Relief

ACETAMINOPHEN - Pain reliever

DIPHENHYDRAMINE HCI / Antihistamine / Cough suppressant

PHENYLEPHRINE HCI - Nasal decognesant

MAXIMUM STRENGTH

Multi-Symptom

Clears sinus congestion
Relieves headache
relieves runny nose & sneezing

For Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Night Time Congestion & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warnings: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such 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 the blood thinning drug warfarin
you are taking sedatives or tranquilizers

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfain
you are taking sedatives or tranquilizers

Structured Label Content

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Uses

temporarily relieves
- nasal congestion
- headache
- minor aches and pains
- cough
- sinus congestion and pressure
- runny nose and sneezing
- temporarily promotes nasal and/or sinus drainage
- controls cough to help you get to sleep

Purposes

Pain Reliever

Antihistamine / cough suppressant

Nasal decongestant

Warnings

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

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

Directions

do not take more than directed (see overdose warning)
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
mL = milliliter
keep dosing cup with product
dose as follows or as directed by a doctor
adults and children 12 years and older:
- 20 mL every 4 hours while symptoms last
children under 12 years of age: do not use

Do Not Use (Do not use)

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist.
with any other drug containing diphenhydramine, even one used on the skin
for children under 12 years of age

Package Label

CVS HEALTH Nighttime Severe Congestion Relief

Other Information (Other information)

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68º-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sodium citrate, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX Night Time Congestion & Cough*

Nighttime

Severe Cough & Congestion Relief

ACETAMINOPHEN - Pain reliever

DIPHENHYDRAMINE HCI / Antihistamine / Cough suppressant

PHENYLEPHRINE HCI - Nasal decognesant

MAXIMUM STRENGTH

Multi-Symptom

Clears sinus congestion
Relieves headache
relieves runny nose & sneezing

For Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Night Time Congestion & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

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 fever, 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.)

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg

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
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such 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 (Ask a Doctor or Pharmacist before use if)

you are taking the blood thinning drug warfarin
you are taking sedatives or tranquilizers

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

you are taking the blood thinning drug warfain
you are taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"": "do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery", "Uses": "temporarily relieves nasal congestion headache minor aches and pains cough sinus congestion and pressure runny nose and sneezing temporarily promotes nasal and/or sinus drainage controls cough to help you get to sleep", "Purposes": "Pain Reliever Antihistamine / cough suppressant Nasal decongestant", "Warnings": "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 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", "Directions": "do not take more than directed (see overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours while symptoms last children under 12 years of age : do not use", "Do not use": "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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin for children under 12 years of age", "Package Label": "CVS HEALTH Nighttime Severe Congestion Relief", "Other information": "each 20 mL contains : sodium 12 mg store between 20-25ºC (68º-77ºF). Do not refrigerate.", "Inactive ingredients": "citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sodium citrate, xanthan gum", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX Night Time Congestion & Cough* Nighttime Severe Cough & Congestion Relief ACETAMINOPHEN - Pain reliever DIPHENHYDRAMINE HCI / Antihistamine / Cough suppressant PHENYLEPHRINE HCI - Nasal decognesant MAXIMUM STRENGTH Multi-Symptom Clears sinus congestion Relieves headache relieves runny nose & sneezing For Ages 12 & Over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Night Time Congestion & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 CVS.com", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "Overdose warnings : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 20 mL)": "Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such 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 the blood thinning drug warfarin you are taking sedatives or tranquilizers", "Ask a Doctor or pharmacist before use if": "you are taking the blood thinning drug warfain you are taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:51.814423 · Updated: 2026-03-14T23:02:39.250584