Indications and 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
Sinus Relief Congestion and Cough
- Manufacturer
- CVS Pharmacy
- Effective date
- 2024-03-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:08:45
Label at a glance#
ProductSinus Relief Congestion and Cough Maximum Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Purposes
Pain Reliever
Antihistamine / cough suppressant
Nasal decongestant
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
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
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
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
When using this product,
- 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
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.
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
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
Package Label
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sinus Relief Congestion and Cough Maximum Strength
- Acetaminophen, Diphenhydramine HCI, Phenylephrine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-461 | 69842-461-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4df833d3-4a43-4916-b0cb-fd70375abddc | d5671a70-8376-4d4e-b29a-21b365eb857a | 2026-05-06 | Warnings | d5671a70-8376-4d4e-b29a-21b365eb857a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.