Albertsons Acetaminophen 650 Mg, Dextromethorphan Hbr 20 Mg, Guaifenesin 400 Mg, Phenylephrine Hcl 10 Mg Liquid

Albertsons Acetaminophen 650 Mg, Dextromethorphan Hbr 20 Mg, Guaifenesin 400 Mg, Phenylephrine Hcl 10 Mg Liquid
SPL v2
SPL
SPL Set ID 202d60a8-83da-5afc-e063-6394a90ad779
Route
ORAL
Published
Effective Date 2025-06-01
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
Propyl Gallate Glycerin Fd&c Blue No. 1 Anhydrous Citric Acid Sucralose Sorbitol Xanthan Gum Trisodium Citrate Dihydrate Edetate Disodium Fd&c Red No. 40 Water Propylene Glycol Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

Warnings



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

■ more than 6 doses in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks daily 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.

Indications and Usage

Uses

■ temporarily relieves these common cold and flu

symptoms:

■ cough

■ nasal congestion

■ minor aches and pains

■ sore throat

■ headache

■ stuffy nose

■ sinus congestion and pressure

■ temporarily reduces fever

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration

Directions

do not take more than directed (see Overdose warning)

■ do not take more than 6 doses in any 24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Description

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Section 34088-5

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur

■ 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 fever, 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

Section 50569-3

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ diabetes

■ high blood pressure

■ thyroid disease

■ trouble urinating due to an enlarged prostate gland

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

■ cough that occurs with too much phlegm (mucus)

Section 50570-1

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.

Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Section 60561-8

Other information

each 20 mL contains: sodium 15 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Structured Label Content

Indications and Usage (34067-9)

Uses

■ temporarily relieves these common cold and flu

symptoms:

■ cough

■ nasal congestion

■ minor aches and pains

■ sore throat

■ headache

■ stuffy nose

■ sinus congestion and pressure

■ temporarily reduces fever

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration (34068-7)

Directions

do not take more than directed (see Overdose warning)

■ do not take more than 6 doses in any 24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Warnings and Precautions (34071-1)

Warnings



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

■ more than 6 doses in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks daily 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.

Section 34088-5 (34088-5)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur

■ 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 fever, 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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ diabetes

■ high blood pressure

■ thyroid disease

■ trouble urinating due to an enlarged prostate gland

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

■ cough that occurs with too much phlegm (mucus)

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Section 60561-8 (60561-8)

Other information

each 20 mL contains: sodium 15 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Advanced Ingredient Data


Raw Label Data

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