Equaline 44-689

Equaline 44-689
SPL v13
SPL
SPL Set ID 90482e7a-d7c7-4127-972d-5ee55e55ed1c
Route
ORAL
Published
Effective Date 2024-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;689 Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-31

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg

Purpose

Antihistamine Cough suppressant


Medication Information

Purpose

Antihistamine

Cough suppressant

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg

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
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
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.

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
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

Questions Or Comments?

1-855-423-2630

Principal Display Panel

EQUALINE®

NDC 41163-698-21

compare to

Coricidin® HBP

Cough & Cold


active ingredients*

cough & cold

relief HBP

chlorpheniramine maleate

(antihistamine)

dextromethorphan HBr

(cough suppressant)

for people with high blood pressure

temporarily relieves:

• cough

• runny nose

• sneezing

16 tablets

DECONGESTANT-FREE

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not

manufactured or distributed by

Bayer HealthCare LLC, owner

of the registered trademark

Coricidin® HBP Cough & Cold.

50844    REV0224C68921

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Equaline 44-689
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.

Active Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

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.


Structured Label Content

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
Purpose

Antihistamine

Cough suppressant

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
Do Not Use (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.

Other Information (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
Inactive Ingredients (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

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel

EQUALINE®

NDC 41163-698-21

compare to

Coricidin® HBP

Cough & Cold


active ingredients*

cough & cold

relief HBP

chlorpheniramine maleate

(antihistamine)

dextromethorphan HBr

(cough suppressant)

for people with high blood pressure

temporarily relieves:

• cough

• runny nose

• sneezing

16 tablets

DECONGESTANT-FREE

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not

manufactured or distributed by

Bayer HealthCare LLC, owner

of the registered trademark

Coricidin® HBP Cough & Cold.

50844    REV0224C68921

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Equaline 44-689
When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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