Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4eafa81a-aeee-4c97-85d6-594902b10919
Route
ORAL
Published
Effective Date 2019-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PH063 Shape: capsule Color: white Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-26

Description

Guaifenesin 400 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
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 73057-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*Compare to the active ingredient in Mucinex ® Tablets

Guaifenesin 400mg

Expectorant

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

Questions?

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

Other Information

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

Inactive Ingredients

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

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 sings 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 Ingredient (in Each Tablet)

Guaifenesin 400 mg

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
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 73057-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*Compare to the active ingredient in Mucinex ® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

Purpose

Expectorant

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

Questions?

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

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 sings 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 Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg

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)