Indications and uses
temporarily relieves these symptoms due to a cold/flu minor aches and pains headache sore throat runny nose sneezing itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever
Flu, Cough and Sore Throat
- Manufacturer
- CVS Pharmacy
- Effective date
- 2023-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:40:15
Label at a glance#
ProductFlu, Cough and Sore Throat
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 (180mg) 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 adults and children 12 years and over: 30 mL every 4 hours children under 12 years of age: do not use
Storage and handling
each 30 mL contains: potassium 10 mg each 30 mL contains: sodium 14mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Antihistamine/
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold/flu
- minor aches and pains
- headache
- sore throat
- runny nose
- sneezing
- itching of the nose or throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
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
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.
Do not use
- to make a child sleepy
- 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 product containing diphenhydramine, even one used on skin
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- glaucoma
- high blood pressure
- heart disease
- diabetes
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- pain, cough, or nasal congestion gets worse, or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditons
If pregnant or breast-feeding,
ask a health professional before use.
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 (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 (180mg) 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
- adults and children 12 years and over:
- 30 mL every 4 hours
- children under 12 years of age: do not use
Other information
- each 30 mL contains: potassium 10 mg
- each 30 mL contains: sodium 14mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Flu, Cough & Sore Throat
ACETAMINOPHEN
Pain reliever; Fever reducer
DIPHENHYDRAMINE HCl
Cough suppressant; Antihistamine
PHENYLEPHRINE HCl
Nasal decongestant
Relief of:
Nasal congestion;
Runny nose; Cough;
Body ache; Sore throat;
Headache; fever
Berry Flavor
Alcohol content 10 %
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® 1-800-SHOP CVS
Product Label
Products#
Every source-derived product name is available through these pages.
- Flu, Cough and Sore Throat
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ALCOHOL
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-653 | 69842-653-08 |
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 |
|---|---|---|---|---|---|---|
| 97037083-a233-4c0e-bcb0-d8fb3363d471 | fd3f2ccc-ae74-4000-888c-7f25e41dbc3d | 2023-01-18 | Warnings | 97037083-a233-4c0e-bcb0-d8fb3363d471 fd3f2ccc-ae74-4000-888c-7f25e41dbc3d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.