Bi-mart 44-012

Bi-mart 44-012
SPL v11
SPL
SPL Set ID f27bb9d1-9880-41f6-b500-42cb5957052a
Route
ORAL
Published
Effective Date 2026-01-02
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
Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Saccharin Sodium Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-18 Until 2023-01-06

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • nasal congestion
    • fever
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

Directions
  • do not take more than directed
  • mL = milliliter; FL OZ = fluid ounce
  • only use the dose cup provided
  • do not take more than 5 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children under 6 years 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.
  • 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
Other Information
  • each 15 mL contains: sodium 13 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients

anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

Questions Or Comments?

1-800-935-6737

Principal Display Panel

BI-MART

Compare to the active ingredients

in Vicks® DayQuil® Cold & Flu*

DAYTIME

COLD & FLU

Acetaminophen (Pain reliever/fever reducer)

Dextromethorphan HBr (Cough suppressant)

Phenylephrine HCl (Nasal decongestant)

Headache, Fever, Sore Throat,

Minor Aches & Pains,

Nasal Congestion,

Cough

Alcohol Free

Menthol Flavored

12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

BI-MART UNCONDITIONAL MONEY BACK GUARANTEE

If you are not completely satisfied with your BI-MART

QUALITY PRODUCT, regardless of the reason, return the

unused portion and your entire purchase price will be

cheerfully refunded.

*This product is not manufactured or

distributed by The Procter & Gamble

Company, distributor of Vicks®

DayQuil® Cold & Flu.

50844   REV0722A01202

Distributed by:

BI-MART

Eugene, OR 97402

Bi-Mart 44-012
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough comes back or occurs with 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.

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 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If the User Has
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • nasal congestion
    • fever
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

Directions
  • do not take more than directed
  • mL = milliliter; FL OZ = fluid ounce
  • only use the dose cup provided
  • do not take more than 5 doses per 24 hours

adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children under 6 years do not use
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.
  • 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
Other Information (Other information)
  • each 15 mL contains: sodium 13 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

1-800-935-6737

Principal Display Panel (Principal display panel)

BI-MART

Compare to the active ingredients

in Vicks® DayQuil® Cold & Flu*

DAYTIME

COLD & FLU

Acetaminophen (Pain reliever/fever reducer)

Dextromethorphan HBr (Cough suppressant)

Phenylephrine HCl (Nasal decongestant)

Headache, Fever, Sore Throat,

Minor Aches & Pains,

Nasal Congestion,

Cough

Alcohol Free

Menthol Flavored

12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

BI-MART UNCONDITIONAL MONEY BACK GUARANTEE

If you are not completely satisfied with your BI-MART

QUALITY PRODUCT, regardless of the reason, return the

unused portion and your entire purchase price will be

cheerfully refunded.

*This product is not manufactured or

distributed by The Procter & Gamble

Company, distributor of Vicks®

DayQuil® Cold & Flu.

50844   REV0722A01202

Distributed by:

BI-MART

Eugene, OR 97402

Bi-Mart 44-012
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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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