Night-time Cold & Flu Relief

Night-time Cold & Flu Relief
SPL v1
SPL
SPL Set ID e2271f60-aad0-4e85-b5b2-9340e815f88b
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 (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Solution Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: CF02 Shape: oval Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01
Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Uses

Temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5

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

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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain 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.

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 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Questions?

call toll-free 1-844-912-4012

Distributed By:

BI-MART

Eugene, OR 97402

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

D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution

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 37835-522-24

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

NIGHTTIME COLD AND FLU RELIEF

Acetaminophen,

Doxylamine Succinate,

Dextromethorphan HBr

24 SoftGels

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

Principal Display Panel 96 Count

NDC 37835-522-96

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

NIGHTTIME COLD AND FLU RELIEF

Acetaminophen,

Doxylamine Succinate,

Dextromethorphan HBr

96 SoftGels

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

Active Ingredients (in Each Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Structured Label Content

Uses

Temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5 (42229-5)

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain 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.

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 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Questions?

call toll-free 1-844-912-4012

Distributed By: (Distributed by:)

BI-MART

Eugene, OR 97402

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

D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution

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 37835-522-24

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

NIGHTTIME COLD AND FLU RELIEF

Acetaminophen,

Doxylamine Succinate,

Dextromethorphan HBr

24 SoftGels

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

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

NDC 37835-522-96

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

NIGHTTIME COLD AND FLU RELIEF

Acetaminophen,

Doxylamine Succinate,

Dextromethorphan HBr

96 SoftGels

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

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

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.006556 · Updated: 2026-03-14T23:07:49.806657