MedPath

COLD, FLU and SORE THROAT RELIEF

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

Approved
Approval ID

202d60a8-83da-5afc-e063-6394a90ad779

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 31, 2025

Manufacturers
FDA

BETTER LIVING BRANDS, LLC

DUNS: 009137209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-909
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2025
FDA Product Classification

INGREDIENTS (17)

PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 20 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 20 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 20 mL
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 20 mL
Code: 04JA59TNSJ
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

![769L-Albertsons-Cold Flu Sore Throat Relief-6Oz-Front label](/dailymed/image.cfm?name=769L-Albertsons- Cold+Flu+Sore+Throat+Relief-6Oz-Front+label.jpg&id=890521)

![IMAGE NAME IMAGE DELETE IMAGE REFERENCED 769L-Albertsons-Cold Flu Sore Throat Relief-6Oz-Back label](/dailymed/image.cfm?name=769L-Albertsons- Cold+Flu+Sore+Throat+Relief-6Oz-Back+label.jpg&id=890521)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/1/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/1/2025

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.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/1/2025

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)

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 6/1/2025

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/1/2025

When using this product do not use more than directed

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/1/2025

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/1/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 6/1/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/1/2025

Other information
each 20 mL contains: sodium 15 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/1/2025

Questions or comments?
Call1-877-290-4008

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