MedPath

Cough and Cold HBP

Signature Select 44-689

Approved
Approval ID

33f34aa2-3b37-4e51-8428-4a12708aa064

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 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.

chlorpheniramine maleate, dextromethorphan HBr

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-689
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
chlorpheniramine maleate, dextromethorphan HBr
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (14)

CHLORPHENIRAMINE MALEATEActive
Quantity: 4 mg in 1 1
Code: V1Q0O9OJ9Z
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/13/2025

Principal display panel

COMPARE TO
****Coricidin® HBP Cough & Cold
Active Ingredients†

Signature****
** SELECT™**

NDC 21130-689-21

Cough &
** Cold HBP**

CHLORPHENIRAMINE MALEATE-Antihistamine
DEXTROMETHORPHAN HBr-Cough Suppressant

Relief of:
•Cough •Runny Nose •Sneezing

Decongestant-free
For People With
High Blood Pressure

Actual Size

16 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
** OPENED OR IF BLISTER UNIT IS TORN, BROKEN**
** OR SHOWS ANY SIGNS OF TAMPERING**

*This product is not manufactured or distributed by
Bayer HealthCare LLC, distributors of Coricidin®
HBP Cough & Cold. 50844 REV0224B68921

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

![Signature Select 44-689](/dailymed/image.cfm?name=signature- select-44-689-1.jpg&id=892574)

Signature Select 44-689

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2025

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves runny nose and sneezing due to the common cold

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

Directions

*do not take more than directed

  • adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/13/2025

Other information

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/13/2025

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

Warnings

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.

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children

  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • avoid alcoholic beverages

  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2025

Purpose

Antihistamine
Cough suppressant

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

Inactive ingredients

croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2025

Questions or comments?

1-800-426-9391

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