cvs 44-075

cvs 44-075
SPL v12
SPL
SPL Set ID 2a569e47-3f17-4fc7-83d6-a3dddfd4987e
Route
oral
Published
Effective Date 2026-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2021-06-10

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • 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.

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.

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sore throat
    • headache
    • stuffy nose
    • the intensity of coughing
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • the impulse to cough to help your child get to sleep
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • this product does not contain directions or complete warnings for adult use
  • do not give more than 5 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • repeat dose every 4 hours while symptoms last
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years: 10 mL in dosing cup provided
  • children under 6 years: do not use
Other Information
  • each 10 mL contains: sodium 5 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Principal Display Panel

♥︎CVS

NDC 69842-475-36

Ages

6–11

years

Mixed Berry Flavor

Children’s

MULTI-SYMPTOM

COLD & FEVER

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr, Cough Suppressant

Guaifenesin, Expectorant

Phenylephrine HCl, Nasal Decongestant

Oral Solution

Relieves: Minor aches & pains,

Fever, Cough, Nasal congestion,

Chest congestion, Stuffy nose

Thins & Loosens Mucus | No Added Alcohol

4 FL OZ (118 mL)

dosing cup

included

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-39965

♥︎ 100% money back

guaranteed.


CVS.com/returnpolicy

50844    ORG082407536

package contains one bottle

actual size

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-075
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.
  • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Questions Or Comments?

1-800-426-9391

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 10 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If the Child Has
  • liver disease
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • 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.

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.

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sore throat
    • headache
    • stuffy nose
    • the intensity of coughing
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • the impulse to cough to help your child get to sleep
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • this product does not contain directions or complete warnings for adult use
  • do not give more than 5 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • repeat dose every 4 hours while symptoms last
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years: 10 mL in dosing cup provided
  • children under 6 years: do not use
Other Information (Other information)
  • each 10 mL contains: sodium 5 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Principal Display Panel (Principal display panel)

♥︎CVS

NDC 69842-475-36

Ages

6–11

years

Mixed Berry Flavor

Children’s

MULTI-SYMPTOM

COLD & FEVER

Acetaminophen

Pain Reliever, Fever Reducer

Dextromethorphan HBr, Cough Suppressant

Guaifenesin, Expectorant

Phenylephrine HCl, Nasal Decongestant

Oral Solution

Relieves: Minor aches & pains,

Fever, Cough, Nasal congestion,

Chest congestion, Stuffy nose

Thins & Loosens Mucus | No Added Alcohol

4 FL OZ (118 mL)

dosing cup

included

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-39965

♥︎ 100% money back

guaranteed.


CVS.com/returnpolicy

50844    ORG082407536

package contains one bottle

actual size

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-075
Do Not Use (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.
  • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)

do not exceed recommended dosage.

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 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 10 Ml) (Active ingredients (in each 10 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • liver disease
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)