Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID af80d10e-3fb2-405a-a803-1f876b8dcd10
Route
ORAL
Published
Effective Date 2019-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone K30 Povidone K90 Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: capsule Color: white Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-18

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Purpose

Expectorant Cough suppressant


Medication Information

Purpose

Expectorant

Cough suppressant

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
Section 42229-5

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex®

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Section 51945-4

PHARBEST 

NDC 73057-381-04

Manufactured in the USA

Immediate Release

PHARBINEX-DM

*Compare to the active ingredient in MUCINEX ® DM Tablets 

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Expectorant & 

Cough Suppressant

30 TABLETS

Directions
  • take with a full glass of water
  • this product can be administered without regard for the timing of the meals
  • do not exceed 6 doses in 24 hours or as directed by a doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

ask a doctor

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 whether your prescription drug contains an MAOI, ask your doctor or pharmacist before using this product.
Other Information

store at 20 0- 25 0C (68 0-77 0F)

Inactive Ingredients

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache

These could be signs of a serious illness.

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 (1-800-222-1222).

Active Ingredients (in Each Tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex®

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Section 51945-4 (51945-4)

PHARBEST 

NDC 73057-381-04

Manufactured in the USA

Immediate Release

PHARBINEX-DM

*Compare to the active ingredient in MUCINEX ® DM Tablets 

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Expectorant & 

Cough Suppressant

30 TABLETS

Purpose

Expectorant

Cough suppressant

Directions
  • take with a full glass of water
  • this product can be administered without regard for the timing of the meals
  • do not exceed 6 doses in 24 hours or as directed by a doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

ask a doctor

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 whether your prescription drug contains an MAOI, ask your doctor or pharmacist before using this product.
Other Information (Other information)

store at 20 0- 25 0C (68 0-77 0F)

Inactive Ingredients (Inactive ingredients)

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache

These could be signs of a serious illness.

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 (1-800-222-1222).

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

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)