day-time cold & flu relief

day-time cold & flu relief
SPL v1
SPL
SPL Set ID 84353861-2146-4107-8e82-8842cfc7ba08
Route
oral
Published
Effective Date 2025-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol 400 povidone k30 propylene glycol water sorbitol solution sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: CF01 Shape: oval Color: orange Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-03-01
Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenlyephrine HCl 5 mg

Medication Information

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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

  • 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.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 aretaking the blood thinning drug warfarin

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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 rash or headache that lasts. These could be signs of a serious condition.
Uses

Temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • sore throat
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Other Information
  • store at room temperature.
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients

FD&C red #40, FD&C yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution.

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenlyephrine HCl 5 mg

Questions?

call toll-free 1-844-912-4012

Section 42229-5

If pregnant or breast-feeding,ask a health professional before use.

Direction
  • take only as directed
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over take 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Distributed By:

BI-MART

Eugene, OR 97402

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Principal Display Panel 24 Count

NDC 37835-520-24

Compare to the active ingredients in Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

DAYTIME COLD AND FLU RELIEF

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

24 SoftGels

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

Principal Display Panel 96 Count

NDC 37835-520-96

Compare to the active ingredients in Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

DAYTIME COLD AND FLU RELIEF

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

96 SoftGels

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

Active Ingredients (in Each Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenlyephrine HCl 5 mg

Structured Label Content

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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

  • 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.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 aretaking the blood thinning drug warfarin

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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 rash or headache that lasts. These could be signs of a serious condition.
Uses

Temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • sore throat
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Other Information (Other information)
  • store at room temperature.
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution.

Questions?

call toll-free 1-844-912-4012

Section 42229-5 (42229-5)

If pregnant or breast-feeding,ask a health professional before use.

Direction
  • take only as directed
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over take 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Distributed By: (Distributed by:)

BI-MART

Eugene, OR 97402

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 (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Principal Display Panel 24 Count (PRINCIPAL DISPLAY PANEL-24 Count)

NDC 37835-520-24

Compare to the active ingredients in Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

DAYTIME COLD AND FLU RELIEF

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

24 SoftGels

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

Principal Display Panel 96 Count (PRINCIPAL DISPLAY PANEL-96 Count)

NDC 37835-520-96

Compare to the active ingredients in Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

DAYTIME COLD AND FLU RELIEF

Acetaminophen,

Phenylephrine HCl,

Dextromethorphan HBr

96 SoftGels

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®DayQuil ®Cold & Flu LiquiCaps ®*

Active Ingredients (in Each Softgels) (Active ingredients (in each softgels))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenlyephrine HCl 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:39.938946 · Updated: 2026-03-14T23:07:49.806657