Kirkland 44-532

Kirkland 44-532
SPL v16
SPL
SPL Set ID 7b543988-7f16-433a-9eaf-a09d3ecaed05
Route
ORAL
Published
Effective Date 2025-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;532 Shape: round Color: blue Size: 13 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-12-22 Until 2021-11-23

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 and make coughs more productive

Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

KIRKLAND

Signature

IMMEDIATE-RELEASE

EXPECTORANT

TABLETS

NDC 63981-532-06

ITM. / ART. 363881 

MUCUS RELIEF

CHEST

Guaifenesin, 400 mg

Expectorant

Actual Size

Relieves Chest Congestion

Thins and Loosens Mucus

Makes Coughs More Productive

2 x 200

Immediate-Release

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844      REV0118H53206

Manufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535 USA

1-800-774-2678

www.costco.com

Kirkland 44-532



Stop Use and Ask A Doctor If

cough persists more than 7 days, 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.

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

Guaifenesin 400 mg


Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purpose

Expectorant

Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

KIRKLAND

Signature

IMMEDIATE-RELEASE

EXPECTORANT

TABLETS

NDC 63981-532-06

ITM. / ART. 363881 

MUCUS RELIEF

CHEST

Guaifenesin, 400 mg

Expectorant

Actual Size

Relieves Chest Congestion

Thins and Loosens Mucus

Makes Coughs More Productive

2 x 200

Immediate-Release

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844      REV0118H53206

Manufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535 USA

1-800-774-2678

www.costco.com

Kirkland 44-532



Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough persists more than 7 days, 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredient (in Each Immediate Release Tablet) (Active ingredient (in each immediate-release tablet))

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

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