Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 73fb2194-a582-4d3c-bc82-c5f110efcd81
Route
ORAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Carbomer 934 Silicon Dioxide Fd&c Blue No. 1 Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Povidone Talc

Identifiers & Packaging

Pill Appearance
Imprint: AN036 Shape: oval Color: blue Size: 16 mm Score: 1
Marketing Status
ANDA Completed Since 2021-09-24 Until 2026-12-30
Description

Guaifenesin 600 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 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 or 2 tablet every 12 hours. Do not exceed 4 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
RITE AID Mucus Relief Tablets
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 Mucinex®*

MUCUS RELIEF

GUAIFENESIN 600 MG

EXPECTORANT

Temporarily relieves chest congestion

Thins & loosen mucus

12 HOUR

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of 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:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.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 600 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 or 2 tablet every 12 hours. Do not exceed 4 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
RITE AID Mucus Relief Tablets
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 Mucinex®*

MUCUS RELIEF

GUAIFENESIN 600 MG

EXPECTORANT

Temporarily relieves chest congestion

Thins & loosen mucus

12 HOUR

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of 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:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.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 600 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:49.718656 · Updated: 2026-03-14T23:09:49.100948