Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e4b27b9b-5f3b-4314-9717-54d73cf6b74e
Route
ORAL
Published
Effective Date 2025-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Carbomer 934 Cellulose, Microcrystalline Povidone Fd&c Blue No. 1 Hypromellose, Unspecified Lactose Monohydrate Talc

Identifiers & Packaging

Pill Appearance
Imprint: AN037 Shape: oval Color: blue Size: 22 mm Score: 1
Marketing Status
ANDA Completed Since 2018-08-31 Until 2026-12-31

Description

Guaifenesin 1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 mg

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use 
Do Not Use

for children under 12 years of age.

Package Label
WALGREENS Maximum Strength Mucus Relief ER
Other Information
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex®††

12 HOUR

Mucus Relief ER

GUAIFENESIN EXTENDED-RELEASE

TABLETS, 1200 mg / EXPECTORANT

Maximum Strength 12 Hour

  • Relieves Chest Congestion
  • Thins & loosens mucus

EXTENDED-RELEASE TABLETS

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

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).

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

Guaifenesin 1200 mg


Structured Label Content

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Purpose

Expectorant

Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use 
Do Not Use (Do not use)

for children under 12 years of age.

Package Label
WALGREENS Maximum Strength Mucus Relief ER
Other Information (Other information)
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients (Inactive ingredients)

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex®††

12 HOUR

Mucus Relief ER

GUAIFENESIN EXTENDED-RELEASE

TABLETS, 1200 mg / EXPECTORANT

Maximum Strength 12 Hour

  • Relieves Chest Congestion
  • Thins & loosens mucus

EXTENDED-RELEASE TABLETS

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

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).

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 accopanied by too much phlegm (mucus)
Active Ingredient (in Each Extended Release tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin 1200 mg


Advanced Ingredient Data


Raw Label Data

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