Meijer Adult Severe Multi-symptom Cough Cold+flu Drug Facts

Meijer Adult Severe Multi-symptom Cough Cold+flu Drug Facts
SPL v3
SPL
SPL Set ID 4cc27b78-5e6d-4993-a851-9e6af32620fa
Route
ORAL
Published
Effective Date 2023-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Potassium Citrate Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-31
Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant

Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use
Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Section 42229-5

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.

Section 44425-7

Other information

  • each 20 ml contains:sodium 7 mg
  • store at room temperature. Do not refrigerate.
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain, cough, or nasal congestion 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.
Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • taking any other pain reliever/fever reducer
Section 50569-3

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)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1

Do not use

  • 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Section 53413-1

Questions or comments?

1-866-467-2748

Sugar-Free

No Added Alcohol

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Liver Warning

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

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

Principal Display Panel

Compare to the active ingredients in Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*

NDC 79481-6300-8

MAXIMUM STRENGTH

Adult

SEVERE

Multi-Symptom

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

  • Cough, Sore Throat
  • Body Aches, Fever
  • Nasal Congestion
  • Chest Congestion

Natural Raspberry Flavor

For Ages 12 & Over

8 FL OZ (237 ml)

*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner of the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.

Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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.

Section 44425-7 (44425-7)

Other information

  • each 20 ml contains:sodium 7 mg
  • store at room temperature. Do not refrigerate.
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain, cough, or nasal congestion 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.
Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • taking any other pain reliever/fever reducer
Section 50569-3 (50569-3)

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)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1 (50570-1)

Do not use

  • 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

1-866-467-2748

Sugar-Free

No Added Alcohol

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Liver Warning (Liver warning)

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

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients in Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*

NDC 79481-6300-8

MAXIMUM STRENGTH

Adult

SEVERE

Multi-Symptom

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

  • Cough, Sore Throat
  • Body Aches, Fever
  • Nasal Congestion
  • Chest Congestion

Natural Raspberry Flavor

For Ages 12 & Over

8 FL OZ (237 ml)

*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner of the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 ml))

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:53.998836 · Updated: 2026-03-14T23:13:10.446567