750l-albertsons-acetaminophen 650mg , Dextromethorphan Hydrobromide 30mg, And Doxylamine Succinate 12.5mg

750l-albertsons-acetaminophen 650mg , Dextromethorphan Hydrobromide 30mg, And Doxylamine Succinate 12.5mg
SPL v1
SPL
SPL Set ID 36924420-f514-4225-e063-6294a90a330c
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 (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Sodium Benzoate Sodium Saccharin Glycerin Fd&c Red No. 40 Propylene Glycol Fd&c Blue No. 1 Alcohol Sodium Citrate Sorbitol Solution Xanthan Gum Polyethylene Glycol, Unspecified Water Sucralose Anhydrous Citric Acid

Identifiers & Packaging

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

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

temporarily relieves common cold/flu symptoms:

■ cough due to minor throat and bronchial irritation

■ sore throat

■ headache

■ minor aches and pains

■ fever

■ runny nose and sneezing

Dosage and Administration

Directions



■ take only as directed

■ only use the dose cup provided

■ do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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



■ 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.

Section 50567-7

When using this product



■ excitability may occur, especially in children

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5

Ask a doctor or pharmacist before use if you are



■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3

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

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

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, 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

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Section 60561-8

Other information

■ each 30 mL contains: sodium 52 mg

■ store at no greater than 25°C and do not refrigerate


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

■ cough due to minor throat and bronchial irritation

■ sore throat

■ headache

■ minor aches and pains

■ fever

■ runny nose and sneezing

Dosage and Administration (34068-7)

Directions



■ take only as directed

■ only use the dose cup provided

■ do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs 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 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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



■ 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.

Section 50567-7 (50567-7)

When using this product



■ excitability may occur, especially in children

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are



■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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

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

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, 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)

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Section 60561-8 (60561-8)

Other information

■ each 30 mL contains: sodium 52 mg

■ store at no greater than 25°C and do not refrigerate


Advanced Ingredient Data


Raw Label Data

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