Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 3ee82152-7c6f-4d93-909d-e1c50eee27e5
Route
ORAL
Published
Effective Date 2025-11-11
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 2019-03-31 Until 2027-02-01
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
DOLLAR GENERAL Maximum Strength Mucus Relief
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 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Maximum Strength Mucinex®*

Maximum Strength

Mucus Relief

Guaifenesin 1200 mg

Expectorant

  • Relieves chest congestion
  • Thins and loosens mucus

Extended-Release Tablets

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of 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 OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072



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 accompanied 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
DOLLAR GENERAL Maximum Strength Mucus Relief
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 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Maximum Strength Mucinex®*

Maximum Strength

Mucus Relief

Guaifenesin 1200 mg

Expectorant

  • Relieves chest congestion
  • Thins and loosens mucus

Extended-Release Tablets

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of 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 OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072



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 accompanied 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:24.590255 · Updated: 2026-03-14T23:13:34.159935